FDA-cleared K253944

Data Analysis Facilitation Suite (DAFS)

Voronoi Health Analytics Incorporated

DAFS automatically segments anatomy on DICOM Part 10 CT images and supports reviewed two- and three-dimensional visualization, editing, and area, volume, and intensity...

Modality
CT/CTA
Anatomy
Multi-region
Decision
2026-03-16
FDA-cleared K253551

VELYS™ Hip Navigation

Depuy Ireland UC

VELYS Hip Navigation analyzes intraoperative X-ray or fluoroscopy for total hip arthroplasty with surgeon-confirmed landmark suggestions and measurements of cup orientation, leg...

Modality
Fluoroscopy/Angiography
Anatomy
Hip
Decision
2026-03-06
FDA-cleared K252500

CARA System

Cara Medical, Ltd.

CARA assists adult structural-heart and conduction-system procedure planning by segmenting preprocedural CT, visualizing cardiac chambers and conduction landmarks, and overlaying...

Modality
Fluoroscopy/Angiography
Anatomy
Heart/Cardiovascular
Decision
2026-02-20
FDA-cleared K250330

3mensio Workstation

Pie Medical Imaging BV

3mensio Workstation is standalone medical-image analysis software for advanced visualization and quantitative analysis of cardiovascular structures. It supports CT, X-ray...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Heart/Cardiovascular
Decision
2025-11-03
FDA-cleared K251059

Syngo Carbon Clinicals (VA41)

Siemens Healthineers AG

Syngo Carbon Clinicals VA41 provides advanced visualization and processing tools for clinical data acquired by multiple imaging modalities, including CT and MR. It supports...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
N/A
Decision
2025-10-24
FDA-cleared K243919

Voxel Dosimetry (00859873006226)

Hermes Medical Solutions AB

Voxel Dosimetry 3.1 calculates voxel-level absorbed-dose maps from post-therapy nuclear-medicine images for FDA-approved therapeutic radiopharmaceuticals and provides reviewed...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2025-07-30
FDA-cleared K243647

Synapse PACS (7.5)

FUJIFILM Healthcare Americas Corporation

Synapse PACS version 7.5 provides primary processing and presentation of DICOM and supported non-DICOM images with measurement, segmentation, fusion, volume rendering, reporting,...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region
Decision
2025-06-30
FDA-cleared K251153

Aurora

GE Medical Systems Israel

Aurora supports planar nuclear medicine, SPECT/CT, uptake analysis, diagnostic and therapy-monitoring workflows, and reviewed deep-learning kidney segmentation for dynamic renal...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2025-06-12
FDA-cleared K250087

Vscan Air

GE Medical Systems Ultrasound and Primary Care Diagnostics

Vscan Air is a wireless handheld point-of-care ultrasound system for broad adult, pediatric, and neonatal applications; K250087 adds reviewed automatic bladder-volume measurement...

Modality
Ultrasound
Anatomy
Multi-region
Decision
2025-05-01
FDA-cleared K241585

uMI Panorama

Shanghai United Imaging Healthcare Co.,Ltd.

uMI Panorama GS combines 148 cm axial-field-of-view PET with CT for qualified healthcare professionals across diagnostic, staging, treatment-planning, and response workflows; this...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Multi-region
Decision
2024-08-30
FDA-cleared K233457

RUS

Hutom Inc.

RUS processes CT images for trained professionals using organ and vessel segmentation, pneumoperitoneum estimation, measurements, paths, and two- or three-dimensional...

Modality
CT/CTA
Anatomy
Chest/Abdomen
Decision
2024-07-12
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 K240642

SMART Bun-Yo-Matic CT

Disior Ltd

SMART Bun-Yo-Matic CT analyzes CT images of the foot and ankle to provide three-dimensional visualizations, measurements, and surgical-planning information for orthopaedic care.

Modality
CT/CTA
Anatomy
Foot/Ankle
Decision
2024-06-20
FDA-cleared K241083

SIS System

Surgical Information Sciences, Inc.

SIS System fuses clinical brain MRI with postoperative CT to visualize DBS anatomy, localize STN, GPe, GPi, and Vim, and segment implanted leads for surgical review.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Brain
Decision
2024-06-14
FDA-cleared K231966

LOGIQ E10

GE Medical Systems Ultrasound and Primary care Diagnostics

LOGIQ E10 is a general-purpose diagnostic ultrasound system for broad adult and pediatric applications; K231966 adds AI-assisted renal measurements, anatomy-based preset and color...

Modality
Ultrasound
Anatomy
Multi-region
Decision
2023-11-07
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
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
FDA-cleared K230082

Auto Segmentation

GE Medical Systems, LLC

Auto Segmentation generates initial DICOM RT Structure Set contours for 40 organs or subregions from adult contrast or noncontrast CT across head and neck, thorax, abdomen, and...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2023-05-04
FDA-cleared K230977

SIS System

Surgical Information Sciences, Inc.

SIS System fuses clinical brain MRI with postoperative CT to visualize DBS anatomy, localize STN, GPe, and GPi, and segment implanted leads for professional review.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Brain
Decision
2023-05-02
FDA-cleared K230552

MR DWI/FLAIR Measurement V1.0

Olea Medical

MR DWI/FLAIR Measurement V1.0 processes brain DWI and FLAIR MRI to calculate ADC maps, segment ADC-hypointense regions, and communicate relative or normalized FLAIR measurements;...

Modality
MRI
Anatomy
Brain
Decision
2023-04-26
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
FDA-cleared K222406

Clarius AI

Clarius Mobile Health Corp.

Clarius AI semi-automatically places calipers for non-invasive measurements of musculoskeletal structures on ultrasound data acquired by the Clarius Ultrasound Scanner.

Modality
Ultrasound
Anatomy
MSK
Decision
2023-01-23
FDA-cleared K221432

Customize

3D-Side SA

Customize supports adult total ankle arthroplasty planning with CT segmentation, three-dimensional models, implant positioning and sizing, treatment-plan review, and...

Modality
CT/CTA
Anatomy
Foot/Ankle
Decision
2022-08-03
FDA-cleared K213779

Customize

3D-Side SA

Customize supports adult shoulder arthroplasty planning with CT segmentation, three-dimensional models, implant positioning and sizing, case management, and physician approval; it...

Modality
CT/CTA
Anatomy
Shoulder
Decision
2022-03-16
FDA-cleared K213544

TOMTEC-ARENA

TOMTEC Imaging Systems GmbH

TOMTEC-ARENA TTA2.50 analyzes ultrasound to quantify and report cardiovascular, fetal, and abdominal structures and functions, including editable AI-assisted echocardiographic...

Modality
Ultrasound
Anatomy
Heart/Cardiovascular
Decision
2022-01-06
FDA-cleared K211881

AI Segmentation

Varian Medical Systems, Inc.

AI Segmentation version 2.0 is a cloud web application that generates initial CT organ-at-risk contours for head and neck, thorax, abdomen, and pelvis for review, editing, and...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2021-09-02
FDA-cleared K203469

AI Segmentation

Varian Medical Systems, Inc.

AI Segmentation version 1.0 is a static, cloud-hosted web application that generates initial CT organ-at-risk contours for head and neck, thorax, abdomen, and pelvis for review...

Modality
Radiotherapy Planning Imaging
Anatomy
Multi-region
Decision
2021-04-19
FDA-cleared K191125

ADAS 3D

Galgo Medical S.L

ADAS 3D post-processes contrast cardiac MRI and CTA to visualize and quantify myocardial scar and export reviewed results to electrophysiology navigation systems; it is not...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Heart/Cardiovascular
Decision
2020-01-15
FDA-cleared K191262

aBSI

EXINI Diagnostics AB

aBSI analyzes nuclear-medicine whole-body bone scans and SPECT to mark lesions and quantify skeletal disease burden as a fraction of total skeletal weight for trained...

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Bone
Decision
2019-08-05
FDA-cleared K181939

icobrain

icometrix NV

icobrain segments and quantifies brain structures and lesions from MRI or noncontrast CT using cross-sectional and longitudinal workflows with acquisition-consistency limits.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Brain
Decision
2018-11-06
FDA-cleared K181892

Ziostation2

Ziosoft, Inc.

Ziostation2 is customer-hardware image-processing software for viewing, quantifying, manipulating, communicating, printing, and managing many radiological image types, with...

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Multi-region
Decision
2018-10-09
FDA-cleared K170981

NeuroQuant

CorTechs Labs, Inc

is a fully automat ed MR imaging post -processing medical device software that provides automatic labeling, visualization and volumetric quantification of brain structures and...

Modality
MRI
Anatomy
Brain
Decision
2017-09-07
FDA-cleared K163622

Lung Vision

BODY VISION MEDICAL LTD.

LungVision segments previously acquired three-dimensional CT data and registers it with live fluoroscopic images to support image-guided pulmonary procedures.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Chest/Lung
Decision
2017-05-11
FDA-cleared K163013

Quantib Brain 1.2

Quantib BV

Quantib Brain is post-processing analysis software for the GE Advantage Workstation (AW 4.7) and AW Server (AWS 3.2) platforms using Volume Viewer Apps. 12.3 Ext 8 (or higher).

Modality
MRI
Anatomy
Brain
Decision
2017-01-06
FDA-cleared K161322

CT CoPilot

ZEPMED, LLC.

CT CoPilotTM is intended for automatic labeling, visualization and volumetric quantification of segmentable structures from sets of CT images of the brain.

Modality
CT/CTA
Anatomy
Brain
Decision
2016-12-07
FDA-cleared K161148

icobrain

Icometrix

icobrain segments and quantifies brain structures and lesions from T1-weighted and FLAIR MRI using cross-sectional and longitudinal workflows with acquisition-consistency limits.

Modality
MRI
Anatomy
Brain
Decision
2016-08-09
FDA-cleared K142037

QUANTRA

HOLOGIC, INC.

Quantra version 2.1 calculates volumetric and area breast-density measures and density categories from supported digital mammography images as an adjunct, not a diagnostic result.

Modality
Mammography/DBT
Anatomy
Breast
Decision
2014-10-10
FDA-cleared K141480

CVI42

CIRCLE CARDIOVASCULAR IMAGING INC

cvi42 analyzes cardiovascular CT and MRI with MPR, MIP, volume rendering, centerlines, lumen and stenosis measurements, and reporting for qualified professionals.

Modality
Radiological images; modality varies or is not specified in FDA list
Anatomy
Heart/Cardiovascular
Decision
2014-08-22
FDA-cleared K082483

QUANTRA

HOLOGIC, INC.

Quantra version 1.1 calculates a volumetric breast-density ratio from supported Hologic full-field digital mammography images on the Cenova server as an adjunct, not a diagnostic...

Modality
Mammography/DBT
Anatomy
Breast
Decision
2008-09-12