Detection and CADe radiology AI tools

FDA-cleared K260729

Vascular Assist Occlusion Triage (VAOT) (v1.0)

GuideAI Health

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Vascular
Decision: 2026-06-18

Detection and CADe Acute triage and notification

FDA-cleared K253825

Saige-Dx

DeepHealth, Inc.

Concurrent detection and characterization support for screening DBT mammography

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2026-06-15

Breast imaging Detection and CADe

FDA-cleared K254075

Synapse Lung Nodule AI

Fujifilm Corporation

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality: CT/CTA
Anatomy: Chest/Lung
Decision: 2026-05-27

Detection and CADe Chest CT

FDA-cleared K254131

BAC

DeepHealth, Inc.

BAC processes screening FFDM and DBT mammograms to detect the presence or absence of breast arterial calcifications at study and breast level and localize detected calcifications...

Modality: Mammography/DBT
Anatomy: Breast; breast arterial calcifications
Decision: 2026-05-21

Breast imaging Detection and CADe

FDA-cleared K261317

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2026-05-14

Detection and CADe Acute triage and notification

FDA-cleared K253682

DeepHealth ProstateAI

Quantib B.V.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: MRI
Anatomy: Prostate
Decision: 2026-04-29

Breast imaging Prostate imaging Detection and CADe

FDA-cleared K260320

Lunit INSIGHT MMG (v1.1.10)

Lunit, Inc.

Lunit INSIGHT MMG v1.1.10 aids physicians in detection, localization and characterization of suspicious breast-cancer areas on female screening mammograms from compatible FFDM...

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2026-04-23

Breast imaging Detection and CADe

FDA-cleared K252190

DeepBT Detector-Plus

Aitewan Biomedical Technology, Inc.

DeepBT Detector-Plus provides initial gross-tumor-volume contours on T1-weighted contrast-enhanced and optional T2-weighted MR images for radiation-treatment planning in adults...

Modality: Radiotherapy Planning Imaging
Anatomy: Brain tumors, including metastases, meningiomas, and acoustic neuromas
Decision: 2026-04-10

Radiotherapy planning Oncology quantification Detection and CADe

FDA-cleared K253796

Lunit INSIGHT DBT (V1.2)

Lunit, Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2026-03-26

Breast imaging Detection and CADe

FDA-cleared K252421

JLK-NCCT

JLK, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2026-03-24

Detection and CADe Acute triage and notification

FDA-cleared K253520

Photonova Spectra, Photonova Spectra Select

Ge Medical Systems, LLC

Photonova Spectra and Spectra Select are silicon-based spectral photon-counting detector CT systems that acquire cross-sectional body images, multienergy data, monochromatic...

Modality: CT/CTA
Anatomy: Head, whole body, heart, vessels, and lungs
Decision: 2026-03-20

Cardiac imaging Detection and CADe

FDA-cleared K252433

Sonio Detect (v3)

Sonio

Sonio Detect v3 analyzes fetal ultrasound images and clips to detect views and anatomical structures and to check labeled image-quality characteristics during acquisition or...

Modality: Ultrasound
Anatomy: Fetal anatomy
Decision: 2026-03-16

Detection and CADe Ultrasound workflow

FDA-cleared K251474

Median LCS (internal name) / eyonis LCS (trade name) (1.0)

Median Technologies

eyonis LCS is a concurrent-reading aid for radiologists that detects, localizes, and characterizes 4-30 mm solid and part-solid pulmonary nodules on low-dose chest CT images for...

Modality: CT/CTA
Anatomy: Chest/Lung
Decision: 2026-02-06

Lung nodule detection Detection and CADe Quantification and segmentation

FDA-cleared K251195

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2026-01-27

Detection and CADe Acute triage and notification

FDA-cleared K251934

qXR-Detect

Qure.Ai Technologies

qXR-Detect is an adult chest-radiograph concurrent reading aid that identifies, highlights and categorizes suspicious regions of interest across lung, pleura,...

Modality: X-ray/Radiography
Anatomy: Chest/Lung; pleura, mediastinum/hila/heart, bone, hardware and other chest-radiograph regions
Decision: 2026-01-16

Cardiac imaging MSK and bone Detection and CADe

FDA-cleared K252934

Diagnocat

DGNCT, LLC

Diagnocat is an automated concurrent-read aid for detecting periapical radiolucency on permanent teeth in previously acquired, clinically justified maxillofacial CBCT; it is a...

Modality: CBCT
Anatomy: Maxillofacial region; permanent teeth; periapical radiolucency
Decision: 2026-01-15

Detection and CADe

FDA-cleared K254001

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)

Spectrum Dynamics Medical, Ltd.

VERITON CT 300/400 Series combines SPECT and CT for detection, localization, diagnosis, staging, restaging, organ-function assessment, therapy planning, guidance, and monitoring....

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Multi-region
Decision: 2026-01-13

Detection and CADe Nuclear medicine

FDA-cleared K252970

BriefCase-Triage: CARE Multi-triage CT Body

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2026-01-07

Detection and CADe Acute triage and notification

FDA-cleared K250959

BioticsAI

Bioticsai, Inc.

BioticsAI assists healthcare professionals during and after fetal ultrasound acquisition and interpretation by detecting views and anatomical structures and facilitating...

Modality: Ultrasound
Anatomy: Obstetric/Fetal
Decision: 2025-12-22

Detection and CADe Ultrasound workflow

FDA-cleared K251203

AVIEW Lung Nodule CAD

Coreline Soft Co.,Ltd

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality: CT/CTA
Anatomy: Chest/Lung
Decision: 2025-12-03

Detection and CADe Chest CT

FDA-cleared K250694

Scaida BrainCT-ICH (v1.0)

Mlhealth 360

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2025-11-25

Detection and CADe Acute triage and notification

FDA-cleared K252366

a2z-Unified-Triage

A2z Radiology Ai, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-11-24

Detection and CADe Acute triage and notification

FDA-cleared K253265

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-11-06

Detection and CADe Acute triage and notification

FDA-cleared K251368

FETOLY

Diagnoly

FETOLY analyzes fetal ultrasound images and sequences to detect labeled fetal brain and heart views, assess image completeness or quality, and provide fetal biometric measurements...

Modality: Ultrasound
Anatomy: Fetal heart and fetal brain
Decision: 2025-09-12

Cardiac imaging Detection and CADe Quantification and segmentation

FDA-cleared K251610

qER-CTA (v1.0)

Qure.ai Technologies

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-09-08

Detection and CADe Acute triage and notification

FDA-cleared K251533

Rapid Obstructive Hydrocephalus, Rapid OH

iSchemaView Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Head/Neck
Decision: 2025-09-04

Detection and CADe Acute triage and notification

FDA-cleared K251983

Brainomix 360 Triage Stroke

Brainomix Limited

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2025-08-26

Detection and CADe Acute triage and notification

FDA-cleared K251590

Methinks CTA Stroke

Methinks Software S.L.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2025-08-20

Detection and CADe Acute triage and notification

FDA-cleared K243341

Genius AI Detection 2.0

Hologic, Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2025-07-31

Breast imaging Detection and CADe

FDA-cleared K251151

Rapid CTA 360

iSchemaView

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-07-16

Detection and CADe Acute triage and notification

FDA-cleared K243884

TAVIPILOT

Caranx Medical

TAVIPILOT detects, tracks, and marks the non-coronary cusp and prosthetic valve on live fluoroscopy during specified adult femoral TAVR or TAVI procedures under physician control.

Modality: Fluoroscopy/Angiography
Anatomy: Heart/Cardiovascular
Decision: 2025-07-07

Cardiac imaging Detection and CADe

FDA-cleared K250685

Methinks NCCT Stroke

Methinks Software S.L.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2025-06-16

Detection and CADe Acute triage and notification

FDA-cleared K243667

Sonic DL

GE Medical Systems, LLC

Sonic DL is optional integrated GE MRI reconstruction for supported 2D cardiac cine and 3D fast-spin-echo or gradient-echo acquisitions at 1.5T, 3T, and 7T for all ages and...

Modality: MRI
Anatomy: Multi-region
Decision: 2025-06-05

Cardiac imaging Detection and CADe

FDA-cleared K243810

TraumaCad Neo (1.1)

Brainlab Ltd.

TraumaCad Neo assists healthcare professionals in analyzing orthopedic conditions and planning orthopedic procedures by overlaying measurements and prosthesis templates on...

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: Hip, knee, upper-limb, and foot orthopedic anatomy represented in X-ray or CT studies
Decision: 2025-06-04

Detection and CADe Quantification and segmentation

FDA-authorized DEN240047

Allix5

Clairity, Inc.

Allix5 generates a five-year breast-cancer-risk prediction from bilateral screening mammograms for eligible patients without known breast cancer at presentation; it is not...

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2025-05-30

Breast imaging Detection and CADe

FDA-cleared K251406

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-05-30

Detection and CADe Acute triage and notification

FDA-cleared K240554

InferRead Lung CT.AI

Infervision Medical Technology Co., Ltd.

Adjunctive pulmonary nodule detection and measurement, including temporal comparison, in chest CT screening of asymptomatic adults aged at least 55 years.

Modality: CT/CTA
Anatomy: Chest/Lung
Decision: 2025-05-16

Lung nodule detection Detection and CADe Quantification and segmentation

FDA-cleared K243239

Lung AI (LAI001)

Exo Inc

Lung AI LAI001 assists trained healthcare professionals performing point-of-care lung ultrasound by detecting and visualizing pleural effusion and consolidation or atelectasis in...

Modality: Ultrasound
Anatomy: Lung; pleural effusion and consolidation or atelectasis at the PLAPS point
Decision: 2025-04-24

Detection and CADe Ultrasound workflow

FDA-cleared K250831

Annalise Enterprise

Annalise-AI

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2025-04-23

Detection and CADe Acute triage and notification

FDA-cleared K242600

Second Opinion Periapical Radiolucency Contours

Pearl Inc.

Second Opinion PC assists dentists by detecting and displaying periapical radiolucencies with bounding polygons on dental radiographs of permanent teeth in patients age 12 and...

Modality: X-ray/Radiography
Anatomy: Dental permanent teeth and periapical region
Decision: 2025-04-11

Detection and CADe

FDA-cleared K243145

syngo.CT LVO Detection

Siemens Medical Solutions USA, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2025-04-10

Detection and CADe Acute triage and notification

FDA-cleared K250754

cmAngio® (V1.6)

CureMetrix, Inc.

cmAngio (V1.6) processes screening mammograms to aid a qualified interpreting physician in the manual process of identifying breast arterial calcification. It detects the presence...

Modality: Mammography/DBT
Anatomy: Female breasts; breast arterial calcification
Decision: 2025-04-10

Breast imaging Detection and CADe Quantification and segmentation

FDA-cleared K243808

Rayvolve PTX-PE

AZmed

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2025-03-21

Detection and CADe Acute triage and notification

FDA-cleared K242683

QP-Prostate® CAD

Quibim S.L.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: MRI
Anatomy: Prostate
Decision: 2025-03-18

Breast imaging Prostate imaging Detection and CADe

FDA-cleared K241725

Better Diagnostics Caries Assist (BDCA) Version 1.0

Better Diagnostics AI Corp

Better Diagnostics Caries Assist is a concurrent-read computer-aided detection device that identifies and localizes carious lesions on bitewing and periapical radiographs of...

Modality: X-ray/Radiography
Anatomy: Dental permanent dentition and carious lesions
Decision: 2025-03-11

Detection and CADe

FDA-cleared K241770

Prostate MR AI (VA10A)

Siemens Healthcare GmbH

Prostate MR AI (VA10A) is a plug-in CADe/CADx aid for radiologists interpreting prostate MRI in adult men aged 40 years or older with suspected prostate cancer and no prior...

Modality: MRI
Anatomy: Prostate
Decision: 2025-03-05

Prostate imaging Detection and CADe

FDA-cleared K243611

JLK-SDH

JLK, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-03-03

Detection and CADe Acute triage and notification

FDA-cleared K242821

EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)

Ever Fortune.AI, Co., Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2025-02-20

Detection and CADe Acute triage and notification

FDA-cleared K250248

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2025-02-14

Detection and CADe Acute triage and notification

FDA-cleared K250035

Contour ProtégéAI+

MIM Software Inc.

Contour ProtégéAI+ automatically creates contours on CT and T2 MR DICOM images as an accessory to MIM software for quantitative analysis, adaptive therapy, transfer, and archive;...

Modality: Radiotherapy Planning Imaging
Anatomy: CT anatomical regions; prostate, seminal vesicles, and urethra on T2 MR
Decision: 2025-02-03

Radiotherapy planning Prostate imaging Detection and CADe

FDA-cleared K242171

TechCare Trauma

Milvue

FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2025-01-17

MSK and bone Detection and CADe

FDA-cleared K243688

Saige-Dx (3.1.0)

DeepHealth, Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2024-12-19

Breast imaging Detection and CADe

FDA-cleared K243538

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)

Shanghai United Imaging Healthcare Co.,Ltd.

The uMI Panvivo PET/CT system provides anatomical and functional images. PET depicts the distribution of approved radiopharmaceuticals and CT provides diagnostic tomographic and...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Whole body and regional anatomy represented in PET/CT studies
Decision: 2024-12-12

Radiotherapy planning Oncology quantification Detection and CADe

FDA-cleared K243548

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-12-11

Detection and CADe Acute triage and notification

FDA-cleared K241923

EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)

Ever Fortune.AI, Co., Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2024-12-06

Detection and CADe Acute triage and notification

FDA-cleared K241747

Saige-Dx

DeepHealth, Inc

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2024-11-18

Breast imaging Detection and CADe

FDA-cleared K241439

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage

Vuno Inc.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2024-11-15

Detection and CADe Acute triage and notification

FDA-cleared K240417

ProFound Detection (V4.0)

iCAD, Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2024-11-08

Breast imaging Detection and CADe

FDA-cleared K240712

icobrain aria

icometrix NV

FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...

Modality: MRI
Anatomy: Brain
Decision: 2024-11-07

MSK and bone Detection and CADe Neuro MRI

FDA-cleared K241719

NeuroICH

Neurocareai Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2024-11-07

Detection and CADe Acute triage and notification

FDA-cleared K242837

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-10-18

Detection and CADe Acute triage and notification

FDA-cleared K242652

Lunit INSIGHT DBT v1.1

Lunit Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2024-10-04

Breast imaging Detection and CADe

FDA-cleared K241480

JBS-LVO

JLK, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2024-09-27

Detection and CADe Acute triage and notification

FDA-cleared K242292

uAI Easy Triage ICH

Shanghai United Imaging Intelligence Co., Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2024-09-24

Detection and CADe Acute triage and notification

FDA-cleared K240036

PIUR tUS Infinity

PIUR Imaging GmbH

PIUR tUS Infinity supports a computer-aided thyroid ultrasound workflow that identifies thyroid lobes and margins, calculates volume, marks and quantifies nodules, and provides...

Modality: Ultrasound
Anatomy: Thyroid
Decision: 2024-09-20

Detection and CADe Quantification and segmentation Ultrasound workflow

FDA-cleared K240942

CINA-CSpine

Avicenna.AI

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Spine
Decision: 2024-09-12

MSK and bone Detection and CADe Acute triage and notification

FDA-cleared K240697

See-Mode Augmented Reporting Tool, Thyroid (SMART-T)

See-Mode Technologies Pte. Ltd.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Ultrasound
Anatomy: N/A
Decision: 2024-09-09

Breast imaging Detection and CADe Ultrasound workflow

FDA-cleared K240003

Velmeni for Dentists (V4D)

Velmeni Inc.

VELMENI for DENTISTS is concurrent-read, computer-assisted detection software intended to assist dentists in the clinical detection of dental caries, fillings or restorations,...

Modality: X-ray/Radiography
Anatomy: Permanent teeth; digital bitewing, periapical, and panoramic dental radiographs
Decision: 2024-08-30

Detection and CADe

FDA-cleared K241596

uMI Panvivo

Shanghai United Imaging Healthcare Co., Ltd.

The uMI Panvivo is a PET/CT system for anatomical and functional images. PET provides distribution information for approved radiopharmaceuticals and CT provides diagnostic...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Whole body and regional anatomy represented in PET/CT studies
Decision: 2024-08-15

Radiotherapy planning Detection and CADe Nuclear medicine

FDA-cleared K240301

MammoScreen® (3)

Therapixel

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2024-08-01

Breast imaging Detection and CADe

FDA-cleared K240845

Rayvolve

AZmed SAS

FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2024-07-17

MSK and bone Detection and CADe

FDA-cleared K241727

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-07-12

Detection and CADe Acute triage and notification

FDA-cleared K240353

Hyper Insight - ICH

SK Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2024-07-01

Detection and CADe Acute triage and notification

FDA-cleared K233662

Radiography 7300 C

Philips Medical Systems DMC GmbH

Radiography 7300 C is a diagnostic radiography system for producing and processing projection X-ray images in the labeled clinical workflow; exact views, detectors, patient...

Modality: X-ray/Radiography
Anatomy: Multi-region
Decision: 2024-06-13

Detection and CADe

FDA-cleared K240612

CINA-VCF

Avicenna.AI

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-05-31

Detection and CADe Acute triage and notification

FDA-cleared K233108

VinDr-Mammo

VinBigData Joint Stock Company

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2024-05-23

Breast imaging Detection and CADe Acute triage and notification

FDA-cleared K233247

Heuron ICH

Heuron Co., Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2024-05-15

Detection and CADe Acute triage and notification

FDA-cleared K232410

SmartChest

Milvue

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2024-05-10

Detection and CADe Acute triage and notification

FDA-cleared K240291

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

Ever Fortune.AI, Co., Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Cardiovascular
Decision: 2024-04-08

Detection and CADe Acute triage and notification

FDA-cleared K232431

syngo.CT Brain Hemorrhage

Siemens Medical Solutions USA, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2024-03-22

Detection and CADe Acute triage and notification

FDA-cleared K233753

AI-Rad Companion (Pulmonary)

Siemens Healthcare GmbH

AI-Rad Companion Pulmonary is image-processing software that provides quantitative and qualitative analysis from previously acquired CT DICOM images to support radiologists and...

Modality: CT/CTA
Anatomy: Adult lungs, lung lobes, pulmonary parenchyma, and solid or sub-solid lung nodules
Decision: 2024-03-21

Lung nodule detection Detection and CADe Quantification and segmentation

FDA-cleared K233968

CINA-iPE

Avicenna.AI

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2024-03-13

Detection and CADe Acute triage and notification

FDA-cleared K231871

Radify Triage

Envisionit DeepAI Ltd

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2024-01-17

Detection and CADe Acute triage and notification

FDA-cleared K233677

Biograph VK10

Siemens Medical Solutions USA, Inc.

The Biograph VK10 combines X-ray CT and PET to register and fuse anatomic and physiologic information, supports independent CT or PET imaging, and aids trained professionals in...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Whole body, cardiovascular, neurological, oncologic, and organ-function imaging
Decision: 2024-01-12

Radiotherapy planning Oncology quantification Detection and CADe

FDA-cleared K232496

Brainomix 360 Triage Stroke

Brainomix Limited

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2023-11-21

Detection and CADe Acute triage and notification

FDA-cleared K223754

BraveCX

Bering Ltd

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2023-11-09

Detection and CADe Acute triage and notification

FDA-cleared K231470

Lunit INSIGHT DBT

Lunit Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2023-11-06

Breast imaging Detection and CADe

FDA-cleared K232751

BriefCase-Triage

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-10-30

Detection and CADe Acute triage and notification

FDA-cleared K232436

Rapid SDH

iSchemaView, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-10-25

Detection and CADe Acute triage and notification

FDA-cleared K230220

NeuViz 128 Multi-Slice CT Scanner System

Neusoft Medical Systems Co., Ltd.

The NeuViz 128 Multi-Slice CT Scanner System is a whole-body computed-tomography X-ray system with a continuously rotating X-ray tube and detector array that reconstructs X-ray...

Modality: CT/CTA
Anatomy: Whole body including head
Decision: 2023-10-11

Detection and CADe

FDA-cleared K232367

cmAngio® V1.0

CureMetrix, Inc.

cmAngio processes screening FFDM and DBT mammograms to detect presence or absence of breast arterial calcifications at study and breast level and mark segments for qualified...

Modality: Mammography/DBT
Anatomy: Breast; breast arterial calcifications
Decision: 2023-10-05

Breast imaging Detection and CADe Quantification and segmentation

FDA-cleared K231025

EFAI NeuroSuite CT ICH Assessment System

Ever Fortune.AI Co., Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2023-10-04

Detection and CADe Acute triage and notification

FDA-cleared K232712

uMI Panorama

Shanghai United Imaging Healthcare Co., Ltd.

uMI Panorama combines PET and CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and fused PET/CT images for qualified...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Multi-region
Decision: 2023-10-03

Oncology quantification Detection and CADe Quantification and segmentation

FDA-cleared K231837

Brainomix 360 Triage LVO

Brainomix Limited

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2023-09-28

Detection and CADe Acute triage and notification

FDA-cleared K231384

Annalise Enterprise CTB Triage Trauma

Annalise-AI Pty Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-09-22

Detection and CADe Acute triage and notification

FDA-cleared K231767

Annalise Enterprise CTB Triage Trauma

Annalise-AI Pty Ltd

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-09-22

Detection and CADe Acute triage and notification

FDA-cleared K231678

Overjet Periapical Radiolucency Assist

Overjet, Inc

Overjet Periapical Radiolucency Assist is a concurrent-read aid for detecting periapical radiolucencies on periapical radiographs of permanent teeth in patients aged 12 years and...

Modality: X-ray/Radiography
Anatomy: Permanent teeth; periapical regions
Decision: 2023-09-21

Detection and CADe

FDA-cleared K223811

Lung-CAD

Imagen Technologies, Inc

Lung-CAD is a concurrent-read computer-aided detection aid for identifying and marking regions of interstitial thickening on adult chest radiographs; it does not provide a...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2023-09-13

Detection and CADe

FDA-cleared K230899

qXR-PTX-PE

Qure.ai Technologies

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2023-08-22

Detection and CADe Acute triage and notification

FDA-cleared K231094

Annalise Enterprise CTB Triage-OH

Annalise-AI Pty Ltd

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-08-15

Detection and CADe Acute triage and notification

FDA-cleared K223133

VisiRad XR

Imidex Inc.

VisiRad XR is a computer-aided detection device that identifies and marks regions of interest suspicious for lung nodules and masses measuring 6-60 mm on chest radiographs in...

Modality: X-ray/Radiography
Anatomy: Adult chest and pulmonary nodules or masses 6-60 mm
Decision: 2023-08-03

Lung nodule detection Detection and CADe

FDA-cleared K230074

Rapid Aneurysm Triage and Notification

iSchemaView Inc.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: CT/CTA
Anatomy: Brain
Decision: 2023-07-27

Detection and CADe Acute triage and notification

FDA-cleared K231195

Brainomix 360 Triage ICH

Brainomix Limited

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2023-07-27

Detection and CADe Acute triage and notification

FDA-cleared K231572

uMI Panorama

Shanghai United Imaging Healthcare Co., Ltd.

uMI Panorama GS combines 148 cm axial-field-of-view PET with CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Multi-region
Decision: 2023-07-26

Detection and CADe Quantification and segmentation Nuclear medicine

FDA-cleared K231157

syngo.CT Lung CAD (Version VD30)

Siemens Healthcare GmbH

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality: CT/CTA
Anatomy: Chest/Lung
Decision: 2023-07-19

Detection and CADe Chest CT

FDA-cleared K231833

Biograph Vision.X and Biograph Vision.X Edge

Siemens Medical Solutions USA, Inc.

The Biograph Vision.X and Biograph Vision.X Edge combine X-ray CT and PET to register and fuse anatomic and physiologic information, support independent CT or PET imaging, aid...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Whole body, cardiovascular, neurological, oncologic, and organ-function imaging
Decision: 2023-07-13

Radiotherapy planning Oncology quantification Detection and CADe

FDA-cleared K223491

Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite

GE Medical Systems, LLC

FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2023-05-25

MSK and bone Detection and CADe

FDA-cleared K230096

Genius AI Detection 2.0 with CC-MLO Correlation

Hologic, Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2023-05-23

Breast imaging Detection and CADe

FDA-cleared K223240

Annalise Enterprise CTB Triage Trauma

Annalise-AI Pty Ltd

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-04-03

Detection and CADe Acute triage and notification

FDA-cleared K222179

Annalise Enterprise CXR Triage Trauma

Annalise-AI Pty Ltd

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2023-03-28

Detection and CADe Acute triage and notification

FDA-cleared K222268

Annalise Enterprise CXR Triage Trauma

Annalise-AI Pty Ltd

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2023-03-28

Detection and CADe Acute triage and notification

FDA-cleared K223443

Viz AAA

Viz. ai, Inc.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-03-17

Detection and CADe Acute triage and notification

FDA-cleared K223325

uMI Panorama

Shanghai United Imaging Healthcare Co., Ltd.

uMI Panorama combines PET and CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and fused PET/CT images for qualified...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Multi-region
Decision: 2023-03-10

Oncology quantification Detection and CADe Quantification and segmentation

FDA-cleared K222176

BoneView

Gleamer

FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...

Modality: X-ray/Radiography
Anatomy: Bone
Decision: 2023-03-02

MSK and bone Detection and CADe

FDA-cleared K222884

Rapid NCCT Stroke

iSchemaView, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2023-03-02

Detection and CADe Acute triage and notification

FDA-cleared K221592

AVIEW Lung Nodule CAD

Coreline Soft Co.,Ltd.

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality: CT/CTA
Anatomy: Chest/Lung
Decision: 2023-02-24

Detection and CADe Chest CT

FDA-cleared K230020

BriefCase

Aidoc Medical, Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: CT/CTA
Anatomy: N/A
Decision: 2023-02-01

Detection and CADe Acute triage and notification

FDA-cleared K222692

BriefCase

Aidoc Medical, Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-12-05

Detection and CADe Acute triage and notification

FDA-cleared K221716

CINA

AVICENNA.AI

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-11-22

Detection and CADe Acute triage and notification

FDA-cleared K221330

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2022-11-18

Detection and CADe Acute triage and notification

FDA-cleared K222428

Syngo Dynamics (Version VA40F)

Siemens Medical Solutions USA, Inc.

Syngo Dynamics VA40F is a multimodality, vendor-agnostic cardiology image and information system for medical-image management and processing, with post-processing functions for...

Modality: Radiological images; modality varies or is not specified in FDA list
Anatomy: Anatomy represented in multimodality cardiology medical images, excluding U.S. digital mammography diagnosis
Decision: 2022-11-14

Breast imaging Detection and CADe Quantification and segmentation

FDA-cleared K221552

EFAI ChestSuite XR Pneumothorax Assessment System

Ever Fortune AI Co., Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2022-11-08

Detection and CADe Acute triage and notification

FDA-cleared K223042

Viz LVO ContaCT

Viz.ai, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2022-10-21

Detection and CADe Acute triage and notification

FDA-cleared K221305

AI-Rad Companion Organs RT

Siemens Medical Solutions USA, Inc

AI-Rad Companion Organs RT VA40 automatically contours predefined structures from adult DICOM CT for qualified review and DICOM RTSTRUCT transfer; this release added 29...

Modality: Radiotherapy Planning Imaging
Anatomy: Multi-region
Decision: 2022-10-14

Radiotherapy planning Detection and CADe

FDA-cleared K220709

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-10-07

Detection and CADe Acute triage and notification

FDA-cleared K221449

Genius AI Detection 2.0

Hologic, Inc.

Genius AI Detection 2.0 analyzes compatible digital breast tomosynthesis images to identify and mark soft-tissue densities and calcifications with confidence scores and case...

Modality: Mammography/DBT
Anatomy: Breast; soft-tissue densities, architectural distortions or asymmetries, and calcifications
Decision: 2022-10-06

Breast imaging Detection and CADe

FDA-cleared K220080

CogNet QmTRIAGE

MedCognetics, Inc.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2022-09-29

Breast imaging Detection and CADe Acute triage and notification

FDA-cleared K222329

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-09-28

Detection and CADe Acute triage and notification

FDA-cleared K221456

Rapid ICH

iSchemaView Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2022-09-12

Detection and CADe Acute triage and notification

FDA-cleared K222076

EFAI ChestSuite XR Pleural Effusion Assessment System

Ever Fortune.AI Co., Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2022-09-08

Detection and CADe Acute triage and notification

FDA-cleared K221241

DrAid for Radiology v1

VinBrain Joint Stock Company

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2022-09-01

Detection and CADe Acute triage and notification

FDA-cleared K222277

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-08-26

Detection and CADe Acute triage and notification

FDA-cleared K221347

Transpara 1.7.2

ScreenPoint Medical B.V.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2022-08-03

Breast imaging Detection and CADe

FDA-cleared K220439

Viz SDH

Viz.ai, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-07-25

Detection and CADe Acute triage and notification

FDA-cleared K212783

ProstatID

ScanMed, LLC

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: MRI
Anatomy: N/A
Decision: 2022-07-08

Breast imaging Detection and CADe

FDA-cleared K221463

ElucidVivo A.3

Elucid Bioimaging Inc.

ElucidVivo A.3 postprocesses contrast multidetector CT to visualize arterial vessels and provide semi-automatic lumen boundaries, stenosis and lumen measurements, vessel length,...

Modality: CT/CTA
Anatomy: Arterial vessels and atherosclerotic disease
Decision: 2022-06-17

Detection and CADe Quantification and segmentation

FDA-cleared K221314

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-06-03

Detection and CADe Acute triage and notification

FDA-cleared K220164

Rayvolve

AZmed SAS

FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2022-06-02

MSK and bone Detection and CADe

FDA-cleared K221248

Rapid LVO

iSchemaView Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2022-05-31

Detection and CADe Acute triage and notification

FDA-cleared K220499

Rapid PE Triage and Notification (PETN)

iSchemaView Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-05-17

Detection and CADe Acute triage and notification

FDA-cleared K221240

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-05-17

Detection and CADe Acute triage and notification

FDA-cleared K220589

MAGNETOM Skyra Fit

Siemens Medical Solutions USA, Inc.

MAGNETOM Skyra Fit with syngo MR XA50A is a 3T system for broad head, body, and extremity MRI; this release includes TSE motion correction and automatic breast-biopsy fiducial...

Modality: MRI
Anatomy: Multi-region
Decision: 2022-05-13

Breast imaging Detection and CADe

FDA-cleared K220105

Saige-Dx

DeepHealth, Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2022-05-12

Breast imaging Detection and CADe

FDA-cleared K212519

Overjet Caries Assist

Overjet, Inc.

Overjet Caries Assist is a concurrent-read aid for detecting and segmenting caries on bitewing radiographs of permanent dentition in patients aged 18 years and older; it provides...

Modality: X-ray/Radiography
Anatomy: Permanent dentition; tooth surfaces and caries
Decision: 2022-05-10

Detection and CADe Quantification and segmentation

FDA-cleared K212915

MVision AI Segmentation

MVision AI

MVision AI Segmentation automatically generates initial contours from CT images for radiotherapy planning; the contours are transferred for professional visualization, review,...

Modality: Radiotherapy Planning Imaging
Anatomy: Head and neck, brain, breast, lung and abdomen, male pelvis, and female pelvis structures
Decision: 2022-05-03

Breast imaging Radiotherapy planning Oncology quantification

FDA-cleared K213886

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-04-26

Detection and CADe Acute triage and notification

FDA-cleared K213721

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2022-03-21

Detection and CADe Acute triage and notification

FDA-cleared K214043

BriefCase

Aidoc Medical, Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2022-03-14

Detection and CADe Acute triage and notification

FDA-cleared K213566

ClearRead Xray Pneumothorax

Riverain Technologies, Inc.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2022-03-10

Detection and CADe Acute triage and notification

FDA-cleared K213941

Annalise Enterprise CXR Triage Pneumothorax

Annalise-AI

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2022-02-24

Detection and CADe Acute triage and notification

FDA-cleared K213319

Viz ANEURYSM, Viz ANX

Viz.ai, Inc.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: CT/CTA
Anatomy: Brain
Decision: 2022-02-18

Detection and CADe Acute triage and notification

FDA-cleared K213976

Contour ProtégéAI

MIM Software Inc.

Contour ProtégéAI creates machine-learning contours from CT and MR DICOM images to support quantitative analysis, adaptive therapy, radiotherapy planning, archiving, and...

Modality: Radiotherapy Planning Imaging
Anatomy: Normal structures in labeled CT locations; prostate, seminal vesicles, and urethra on T2 MR
Decision: 2022-02-03

Radiotherapy planning Prostate imaging Detection and CADe

FDA-cleared K203260

syngo.CT Brain Hemorrhage

Siemens Medical Solutions USA, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2022-01-28

Detection and CADe Acute triage and notification

FDA-cleared K210760

Precise Image

Philips Medical Systems Nederland, B.V.

Precise Image is an adult head-and-body CT reconstruction application for selected Philips Incisive CT protocols that uses a convolutional neural network to reduce noise and...

Modality: CT/CTA
Anatomy: Multi-region
Decision: 2022-01-14

Detection and CADe

FDA-cleared K210670

BU-CAD

TaiHao Medical Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Ultrasound
Anatomy: N/A
Decision: 2021-12-21

Breast imaging Detection and CADe Ultrasound workflow

FDA-cleared K211803

HealthPPT

Zebra Medical Vision Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2021-12-15

Detection and CADe Acute triage and notification

FDA-cleared K211541

MammoScreen 2.0

Therapixel

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2021-11-26

Breast imaging Detection and CADe

FDA-cleared K211678

Lunit INSIGHT MMG

Lunit Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2021-11-17

Breast imaging Detection and CADe

FDA-cleared K211733

Lunit INSIGHT CXR Triage

Lunit Inc.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2021-11-10

Detection and CADe Acute triage and notification

FDA-cleared K212261

StrokeSENS LVO

Circle Neurovascular Imaging, Inc

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2021-10-14

Detection and CADe Acute triage and notification

FDA-cleared K211945

V8 Diagnostic Ultrasound System

Samsung Medison CO., LTD.

Samsung V8 is a general diagnostic ultrasound system for broad hospital, clinic, and practice applications; K211945 adds thoracic scanning, AI-based NerveTrack, and AI-based...

Modality: Ultrasound
Anatomy: Multi-region
Decision: 2021-09-08

Detection and CADe Quantification and segmentation Ultrasound workflow

FDA-cleared K212383

EndoNaut

Therenva SAS

EndoNaut overlays preoperative three-dimensional vascular anatomy on live fluoroscopy and supports semi-automatic registration and motion detection for selected aneurysm,...

Modality: Fluoroscopy/Angiography
Anatomy: Multi-region
Decision: 2021-08-31

Detection and CADe

FDA-cleared K211179

InferRead CT Stroke.AI

Infervision Medical Technology Co., Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2021-08-12

Detection and CADe Acute triage and notification

FDA-cleared K211764

Vereos PET/CT

Philips Medical Systems Nederland B.V.

Vereos PET/CT detects, localizes, diagnoses, stages, restages, and follows treatment response in oncology, cardiology, and neurology and can provide diagnostic CT and...

Modality: PET/SPECT/Nuclear Medicine
Anatomy: Multi-region
Decision: 2021-08-06

Radiotherapy planning Oncology quantification Detection and CADe

FDA-cleared K211788

HALO

Nico.Lab B.V.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2021-07-08

Detection and CADe Acute triage and notification

FDA-cleared K210404

Transpara 1.7.0

ScreenPoint Medical B.V.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2021-06-02

Breast imaging Detection and CADe

FDA-cleared K210237

CINA CHEST

Avicenna.AI

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Chest/Lung
Decision: 2021-05-19

Detection and CADe Acute triage and notification Chest CT

FDA-cleared K203517

Saige-Q

DeepHealth, Inc.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2021-04-16

Breast imaging Detection and CADe Acute triage and notification

FDA-cleared K202992

BriefCase, RIB Fractures Triage (RibFx)

Aidoc Medical, Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: CT/CTA
Anatomy: Bone
Decision: 2021-04-14

MSK and bone Detection and CADe Acute triage and notification

FDA-cleared K203258

syngo.CT Lung CAD

Siemens Healthcare GmbH

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality: CT/CTA
Anatomy: Chest/Lung
Decision: 2021-03-31

Detection and CADe Chest CT

FDA-cleared K210209

Viz ICH

Viz.ai, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2021-03-23

Detection and CADe Acute triage and notification

FDA-cleared K203822

ProFound AI Software V3.0

iCAD Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2021-03-12

Breast imaging Detection and CADe

FDA-cleared K210053

LVivo Software Application

DiA Imaging Analysis Ltd

LVivo Software Application non-invasively processes ultrasound images to detect, measure, and calculate relevant medical parameters of patient structures and function in patients...

Modality: Ultrasound
Anatomy: Structures and function represented in supported ultrasound examinations
Decision: 2021-02-05

Detection and CADe Quantification and segmentation Ultrasound workflow

FDA-cleared K193271

uAI EasyTriage-Rib

Shanghai United Imaging Intelligence Co., Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: CT/CTA
Anatomy: N/A
Decision: 2021-01-15

Detection and CADe Acute triage and notification

FDA-cleared K201019

Genius AI Detection

Hologic, Inc.

Genius AI Detection analyzes compatible digital breast tomosynthesis images to identify and mark soft-tissue densities and calcifications with confidence scores and case scoring...

Modality: Mammography/DBT
Anatomy: Breast; soft-tissue densities and calcifications in digital breast tomosynthesis
Decision: 2020-11-18

Breast imaging Detection and CADe

FDA-cleared K193562

AI-Rad Companion Organs RT

Siemens Medical Solutions USA, Inc.

AI-Rad Companion Organs RT VA20 automatically contours predefined organs at risk from adult DICOM CT for qualified review, editing, and DICOM RTSTRUCT transfer into...

Modality: Radiotherapy Planning Imaging
Anatomy: Multi-region
Decision: 2020-11-06

Radiotherapy planning Detection and CADe

FDA-cleared K202546

LVivo Seamless

DiA Imaging Analysis Ltd

LVivo Seamless non-invasively processes ultrasound images to detect, measure, and calculate relevant medical parameters of patient structures and function in patients with...

Modality: Ultrasound
Anatomy: Structures and function represented in supported ultrasound examinations
Decision: 2020-09-29

Detection and CADe Quantification and segmentation Ultrasound workflow

FDA-cleared K201310

Accipiolx

MaxQ Al Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-08-07

Detection and CADe Acute triage and notification

FDA-cleared K193417

FractureDetect (FX)

Imagen Technologies, Inc.

FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...

Modality: X-ray/Radiography
Anatomy: Bone
Decision: 2020-07-30

MSK and bone Detection and CADe

FDA-cleared K200905

HealthMammo

Zebra Medical Vision Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2020-07-16

Breast imaging Detection and CADe Acute triage and notification

FDA-cleared K200941

Rapid LVO

iSchemaView Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2020-07-09

Detection and CADe Acute triage and notification

FDA-cleared K193073

Deep Recon

Shanghai United Imaging Healthcare Co., Ltd.

Deep Recon is a data-driven deep-learning CT reconstruction method for axial, helical, and cardiac acquisitions. It is designed to generate lower-noise CT images, improve...

Modality: CT/CTA
Anatomy: Adult head, chest, abdomen, cardiac, and vascular CT
Decision: 2020-07-06

Cardiac imaging Detection and CADe

FDA-cleared K192880

InferRead Lung CT.AI

Beijing Infervision Technology Co.,Ltd.

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality: CT/CTA
Anatomy: Chest/Lung
Decision: 2020-07-02

Detection and CADe Chest CT

FDA-cleared K200855

CINA

AVICENNA.AI

CINA analyzes nonenhanced head CT for suspected intracranial hemorrhage and head CTA for suspected large-vessel occlusion for computer-aided triage and notification in parallel...

Modality: CT/CTA
Anatomy: Brain
Decision: 2020-06-24

Stroke and ICH triage Detection and CADe Acute triage and notification

FDA-cleared K193298

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-06-19

Detection and CADe Acute triage and notification

FDA-cleared K200921

qER

Qure.ai Technologies

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-06-17

Detection and CADe Acute triage and notification

FDA-cleared K192901

HealthVCF

Zebra Medical Vision Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-05-12

Detection and CADe Acute triage and notification

FDA-cleared K193351

NinesAI

Nines, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2020-04-21

Detection and CADe Acute triage and notification

FDA-cleared K192167

CuraRad-ICH

CuraCloud Corp.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2020-04-13

Detection and CADe Acute triage and notification

FDA-cleared K193300

AIMI-Triage CXR PTX

RADLogics, Inc.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2020-04-08

Detection and CADe Acute triage and notification

FDA-cleared K193087

Rapid ICH

iSchemaView Incorporated

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2020-03-31

Detection and CADe Acute triage and notification

FDA-cleared K193658

Viz ICH

Viz.ai, Inc.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: Brain
Decision: 2020-03-18

Detection and CADe Acute triage and notification

FDA-cleared K193216

syngo.CT Lung CAD

Siemens Medical Solutions, Inc

FDA product code OEB identifies this device class as Lung Computed Tomography System, Computer-Aided Detection. To assist radiologists in the review of multi-slice computed...

Modality: CT/CTA
Anatomy: Chest/Lung
Decision: 2020-03-09

Detection and CADe Chest CT

FDA-cleared K191556

Red Dot

Behold.AI Technologies Limited

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2020-02-28

Detection and CADe Acute triage and notification

FDA-cleared K192383

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-12-20

Detection and CADe Acute triage and notification

FDA-cleared K192320

HealthCXR

Zebra Medical Vision, Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: Chest/Lung
Decision: 2019-11-26

Detection and CADe Acute triage and notification

FDA-cleared K191994

ProFound AI Software V2.1

iCAD Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2019-10-04

Breast imaging Detection and CADe

FDA-cleared K183182

Critical Care Suite

GE Medical Systems, LLC.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2019-08-12

Detection and CADe Acute triage and notification

FDA-cleared K182875

DeepCT

Deep01 Limited

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-07-10

Detection and CADe Acute triage and notification

FDA-cleared K190424

HealthICH

Zebra Medical Vision Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-06-13

Detection and CADe Acute triage and notification

FDA-cleared K190896

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-05-31

Detection and CADe Acute triage and notification

FDA-cleared K190362

HealthPNX

Zebra Medical Vision Ltd.

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2019-05-06

Detection and CADe Acute triage and notification

FDA-cleared K190072

BriefCase

Aidoc Medical, Ltd.

FDA product code QAS identifies this device class as Radiological Computer-Assisted Triage And Notification Software. Radiological computer-assisted triage and notification...

Modality: CT/CTA
Anatomy: N/A
Decision: 2019-04-15

Detection and CADe Acute triage and notification

FDA-cleared K183285

cmTriage

CureMetrix, Inc

FDA product code QFM identifies this device class as Radiological Computer-Assisted Prioritization Software For Lesions. Radiological computer-assisted prioritization software for...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2019-03-08

Breast imaging Detection and CADe Acute triage and notification

FDA-cleared K180867

AmCAD-UO

AmCad BioMed Corporation

AmCAD-UO analyzes pharyngeal and upper-airway ultrasonic images to visualize and quantify airway structures for physician evaluation and monitoring.

Modality: Ultrasound
Anatomy: Head/Neck
Decision: 2018-12-28

Detection and CADe Quantification and segmentation Ultrasound workflow

FDA-cleared K183012

vascuCAP

Elucid Bioimaging Inc.

vascuCAP analyzes contrast multidetector CT of arterial vessels to support atherosclerosis stratification with color maps, three-dimensional views, multiplanar reformats, and...

Modality: CT/CTA
Anatomy: Heart/Cardiovascular
Decision: 2018-12-21

Cardiac imaging Detection and CADe Quantification and segmentation

FDA-cleared K182373

PowerLook Tomo Detection V2 Software

iCAD Inc.

FDA product code QDQ identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer. A radiological computer...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2018-12-06

Breast imaging Detection and CADe

FDA-cleared K181572

Workflow Box

Mirada Medical Ltd.

Workflow Box is a software system for routing DICOM-compliant data to and from automated processing components. It supports atlas-based contouring, deformable-image-registration...

Modality: Radiotherapy Planning Imaging
Anatomy: CT, MR, and RTSTRUCT imaging data for automated contours and radiotherapy planning
Decision: 2018-07-10

Radiotherapy planning Detection and CADe

FDA-authorized DEN180005

OsteoDetect

Imagen Technologies, Inc.

FDA product code QBS identifies this device class as Radiological Computer Assisted Detection/Diagnosis Software For Fracture. A radiological computer assisted detection and...

Modality: X-ray/Radiography
Anatomy: N/A
Decision: 2018-05-24

MSK and bone Detection and CADe

FDA-cleared K170069

AmCAD-UV

AmCad BioMed Corporation

AmCAD-UV classifies ultrasonic color-intensity data and lets users view primary pulsatile, secondary pulsatile, and unidentified signals in flow-Doppler ultrasound images. It is a...

Modality: Ultrasound
Anatomy: Vascular structures; pulsatile flow signals
Decision: 2017-04-26

Detection and CADe Ultrasound workflow

FDA-approved P160009

PowerLook® Tomo Detection Software

iCAD Inc

PowerLook Tomo Detection Software is a concurrent computer-aided detection tool for radiologists reading GE Senoclaire breast tomosynthesis examinations; it detects soft-tissue...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2017-03-24

Breast imaging Detection and CADe

FDA-cleared K161959

ClearView cCAD

ClearView Diagnostics Inc.

ClearView cCAD is a software application designed to assist skilled physicians in analyzing breast ultrasound images.

Modality: Ultrasound
Anatomy: Breast
Decision: 2016-12-28

Breast imaging Detection and CADe Ultrasound workflow

FDA-approved P150043

QVCAD System

QView Medical, Inc.

The QVCAD System is indicated as an aid to the reader during screening procedures in searching images of female breasts produced by the somo.v Automated Breast Ultrasound System,...

Modality: Ultrasound
Anatomy: Female breasts; mammography-occult lesions in non-suspicious regions
Decision: 2016-11-09

Breast imaging Detection and CADe Ultrasound workflow

FDA-cleared K161201

ClearRead CT

RIVERAIN TECHNOLOGIES, LLC

ClearRead CT is a post-processing adjunct for detecting pulmonary nodules on chest CT in an asymptomatic population; it generates a secondary vessel-suppressed lung CT with CADe...

Modality: CT/CTA
Anatomy: Chest/lungs
Decision: 2016-09-09

Lung nodule detection Detection and CADe

FDA-cleared K161382

LVivo Software Application

DIACARDIO, LTD.

LVivo Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular...

Modality: Ultrasound
Anatomy: Heart
Decision: 2016-07-28

Cardiac imaging Detection and CADe Quantification and segmentation

FDA-approved P010034

SECOND LOOK ™

ICAD, INC.

The Second Look computer-aided detection system for mammography is intended to identify and mark regions of interest on standard mammographic views after the initial reading has...

Modality: Mammography/DBT
Anatomy: Breast / standard mammographic views
Decision: 2002-01-31

Breast imaging Detection and CADe

FDA-approved P000041

RAPIDSCREEN RS-2000

RIVERAIN MEDICAL GROUP

RAPIDSCREEN RS-2000 is a PMA-authorized computer-aided detection device that identifies and marks regions of interest on digitized frontal chest radiographs associated with...

Modality: X-ray/Radiography
Anatomy: Adult chest; solitary pulmonary nodules 9-30 mm
Decision: 2001-07-12

Lung nodule detection Detection and CADe

FDA-approved P980025

LOGICON CARIES DETECTOR

CARESTREAM DENTAL LLC

LOGICON Caries Detector is adjunct software for detecting caries extending into dentin on unrestored proximal surfaces of secondary dentition in supported digital intraoral...

Modality: X-ray/Radiography
Anatomy: Dental/Maxillofacial
Decision: 1998-09-02

Detection and CADe