FDA-cleared K252538

CEPHX3D

Orca Dental AI, Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2026-03-05
FDA-cleared K251934

qXR-Detect

Qure.Ai Technologies

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2026-01-16
FDA-cleared K250914

MediAI-BA

Crescom Co., Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2025-12-18
FDA-cleared K252086

DTX Studio Assist

Nobel Biocare C/O Medicim NV

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2025-11-17
FDA-cleared K250525

Second Opinion® Panoramic

Pearl, Inc.

Second Opinion Panoramic analyzes panoramic dental radiographs for patients 16 years and older, marking suspected caries, periapical radiolucencies, and impacted third molars as a...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2025-11-14
FDA-cleared K251078

AutoDensity

Eos Imaging

AutoDensity estimates L1-L4 spine bone-mineral density from EOSedge dual-energy AP radiographs for opportunistic orthopedic pre-surgical assessment; it is not a replacement for...

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2025-11-14
FDA-cleared K250264

SugarBug (1.x)

Bench7, Inc.

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2025-11-07
FDA-cleared K252214

AIAS Cephalon

Metamorphosis GmbH

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
Head/Neck
Decision
2025-10-07
FDA-cleared K251002

Videa Dental AI

VideaHealth Inc.

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2025-09-19
FDA-cleared K251167

uDR Aurora CX

Shanghai United Imaging Healthcare Co., Ltd.

FDA product code KPR identifies this device class as System, X-Ray, Stationary. Consult the linked FDA record for the exact authorized indications for use.

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2025-09-19
FDA-cleared K251931

BioTraceIO Vision (V1.7)

Techsomed Medical Technologies

FDA product code QTZ identifies this device class as Radiological Image Processing Software For Ablation Therapy Planning And Evaluation. To provide radiological image processing...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2025-09-08
FDA-cleared K250753

VELMENI for DENTISTS (V4D)

Velmeni Inc.

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2025-09-02
FDA-cleared K251408

OsteoSight™ Hip (v1)

Naitive Technologies Ltd

FDA product code SAO identifies this device class as Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density. This device is software which opportunistically...

Modality
X-ray/Radiography
Anatomy
Hip
Decision
2025-09-02
FDA-cleared K250788

Definium Tempo Select

GE Hualun Medical Systems Co., Ltd

FDA product code KPR identifies this device class as System, X-Ray, Stationary. Consult the linked FDA record for the exact authorized indications for use.

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2025-08-28
FDA-cleared K251747

VEA Align; spineEOS

EOS imaging

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2025-08-15
FDA-cleared K250738

YSIO X.pree

Siemens Medical Solutions

FDA product code KPR identifies this device class as System, X-Ray, Stationary. Consult the linked FDA record for the exact authorized indications for use.

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2025-07-31
FDA-cleared K243234

Second Opinion® CS

Pearl Inc.

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2025-06-12
FDA-cleared K243005

AudaxCeph Cephalogram Analysis Software

Audax d.o.o.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
Head/Neck
Decision
2025-05-30
FDA-cleared K250367

CoLumboX

Smart Soft Healthcare AD

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2025-05-28
FDA-cleared K242437

Smile Dx®

Cube Click, Inc.

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2025-05-14
FDA-cleared K243893

Second Opinion® Pediatric

Pearl, Inc.

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2025-05-05
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
FDA-cleared K243831

Rayvolve LN

AZmed

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2025-03-26
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
FDA-cleared K241620

ChestView US

Gleamer SAS

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2025-02-27
FDA-cleared K241593

BoneMetrics (US)

Gleamer SAS

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
Bone
Decision
2025-02-05
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
FDA-cleared K242522

Second Opinion CC

Pearl Inc.

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2025-01-16
FDA-cleared K241696

Ortho AI

Ortho AI LLC

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2025-01-02
FDA-cleared K241681

Overjet Image Enhancement Assist

Overjet Inc

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2024-09-09
FDA-cleared K240003

Velmeni for Dentists (V4D)

Velmeni Inc.

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2024-08-30
FDA-cleared K241684

Overjet Charting Assist

Overjet, Inc

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2024-08-27
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
FDA-cleared K240736

SMART Bun-Yo-Matic X-Ray

Disior Ltd

SMART Bun-Yo-Matic X-Ray analyzes foot and ankle X-rays to provide visualizations, measurements, and surgical-planning information for orthopaedic care.

Modality
X-ray/Radiography
Anatomy
Foot/Ankle
Decision
2024-07-02
FDA-cleared K240582

VEA Align; spineEOS

EOS imaging

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2024-06-25
FDA-cleared K233662

Radiography 7300 C

Philips Medical Systems DMC GmbH

FDA product code KPR identifies this device class as System, X-Ray, Stationary. Consult the linked FDA record for the exact authorized indications for use.

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2024-06-13
FDA-cleared K234042

EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)

Ever Fortune.AI Co., Ltd.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
Bone
Decision
2024-06-07
FDA-cleared K233543

YSIO X.pree

Siemens Medical Solutions

FDA product code KPR identifies this device class as System, X-Ray, Stationary. Consult the linked FDA record for the exact authorized indications for use.

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2024-05-21
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
FDA-cleared K240773

VisAble.IO

Techsomed

FDA product code QTZ identifies this device class as Radiological Image Processing Software For Ablation Therapy Planning And Evaluation. To provide radiological image processing...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2024-04-15
FDA-authorized DEN230023

Rho

16 Bit Inc

FDA product code SAO identifies this device class as Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density. This device is software which opportunistically...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2024-04-09
FDA-cleared K233738

Overjet Caries Assist-Pediatric

Overjet, Inc

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2024-03-04
FDA-cleared K233590

Overjet Charting Assist

Overjet, Inc

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2024-02-23
FDA-cleared K231396

CEPHX- Cephalometric Analysis Software

Orca Dental AI LTD

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
X-ray/Radiography
Anatomy
Head/Neck
Decision
2024-01-31
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
FDA-cleared K231917

VEA Align

EOS imaging

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2024-01-05
FDA-cleared K231805

qXR-LN

Qure.ai Technologies

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2023-12-22
FDA-cleared K232384

Videa Dental Assist

VideaHealth, Inc.

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2023-12-15
FDA-cleared K231898

DTX Studio Clinic (4.0)

Nobel Biocare AB

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2023-12-08
FDA-cleared K232440

Adravision Perio

Adra Corporation

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2023-12-05
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
FDA-cleared K230144

Denti.AI Detect

Denti.AI Technology, Inc.

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2023-10-06
FDA-cleared K231001

DeepTek CXR Analyzer v1.0

DeepTek Medical Imaging Pvt Ltd

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2023-10-05
FDA-cleared K230085

Lung-CAD

Imagen Technologies, Inc

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2023-10-03
FDA-cleared K231149

qXR-CTR

Qure.ai Technologies

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2023-09-22
FDA-cleared K223811

Lung-CAD

Imagen Technologies, Inc

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2023-09-13
FDA-cleared K223621

DeepXray

Alpha Intelligence Manifolds, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2023-09-08
FDA-cleared K223639

VisAble.IO

TechsoMed

FDA product code QTZ identifies this device class as Radiological Image Processing Software For Ablation Therapy Planning And Evaluation. To provide radiological image processing...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2023-08-28
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
FDA-cleared K223133

VisiRad XR

Imidex Inc.

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2023-08-03
FDA-cleared K231668

Spine CAMP™ (1.1)

Medical Metrics, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2023-07-07
FDA-cleared K223646

IB Lab LAMA

IB Lab GmbH

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2023-06-16
FDA-cleared K221921

DTX Studio Clinic 3.0

Nobel Biocare AB

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2023-03-28
FDA-cleared K222746

Overjet Caries Assist

Overjet, Inc.

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2023-03-27
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
FDA-cleared K223296

Videa Perio Assist

VideaHealth, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2023-02-06
FDA-cleared K220928

Overjet Calculus Assist

Overjet Inc.

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2022-12-16
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
FDA-cleared K221632

Spine CAMP™

Medical Metrics, Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2022-10-18
FDA-cleared K213353

Aorta-CAD

Imagen Technologies, Inc

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
Cardiovascular
Decision
2022-09-20
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
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
FDA-cleared K213795

Videa Caries Assist

VideaHealth, Inc

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2022-04-21
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
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
FDA-cleared K210365

Second Opinion

Pearl Inc.

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2022-03-04
FDA-cleared K212654

Micro C Medical Imaging System, M01

OXOS Medical, Inc.

FDA product code IZL identifies this device class as System, X-Ray, Mobile. Consult the linked FDA record for the exact authorized indications for use.

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2022-02-04
FDA-cleared K212005

UNiD Spine Analyzer

MEDICREA International, Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
X-ray/Radiography
Anatomy
Spine
Decision
2022-01-12
FDA-cleared K212690

qXR-BT

Qure.ai Technologies

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2021-12-21
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
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
FDA-cleared K212269

Intelligent NR

Canon Inc.

FDA product code MQB identifies this device class as Solid State X-Ray Imager (Flat Panel/Digital Imager). Consult the linked FDA record for the exact authorized indications for...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2021-09-17
FDA-cleared K201560

Auto Lung Nodule Detection

Samsung Electronics Co.,Ltd.

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2021-08-31
FDA-cleared K203696

RBknee

Radiobotics ApS

Indications for Use statement. Please note that the 510(k) submission was not re-reviewed.

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2021-08-27
FDA-cleared K210666

Chest-CAD

Imagen Technologies, Inc

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
Chest/Lung
Decision
2021-07-20
FDA-cleared K210187

Overjet Dental Assist

Overjet, Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2021-05-19
FDA-cleared K202441

Eclipse II with Smart Noise Cancellation

Carestream Health, Inc.

FDA product code MQB identifies this device class as Solid State X-Ray Imager (Flat Panel/Digital Imager). Consult the linked FDA record for the exact authorized indications for...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2021-04-02
FDA-cleared K202487

HealthJOINT

Zebra Medical Vision Ltd.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2020-12-04
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
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
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
FDA-cleared K192279

PhantomMSK Trauma

OrthoGrid Systems Inc.

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2019-12-07
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
FDA-cleared K192109

KOALA

IB Lab GmbH

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2019-11-05
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
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
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
FDA-cleared K133259

YSIO MAX

SIEMENS MEDICAL SOLUTIONS USA, INC.

FDA product code KPR identifies this device class as System, X-Ray, Stationary. Consult the linked FDA record for the exact authorized indications for use.

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2014-01-24
FDA-cleared K123526

CLEARREAD +CONFIRM

RIVERAIN TECHNOLOGIES

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2012-12-27
FDA-cleared K111776

DELTAVIEW MODEL 2.1

RIVERAIN MEDICAL GROUP,LLC

FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2011-12-28
FDA-approved P000041

RAPIDSCREEN RS-2000

RIVERAIN MEDICAL GROUP

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
2001-07-12
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
FDA-approved P970058

M1000 IMAGECHECKER

Hologic, Inc.

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
X-ray/Radiography
Anatomy
N/A
Decision
1998-06-26