Breast imaging radiology AI tools

Infinitt PACS 7.0 device is PACS software capable of viewing and handling DICOM 3.x medical images. The System allows displaying of images and image studies that may not in the...

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2017-10-27

Breast imaging

FDA-cleared K173420

Radiomics App v1.0

Microsoft Corp.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2017-12-27

Breast imaging

FDA-cleared K173588

Illumeo System

Philips Medical Systems Technologies, Ltd.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2018-01-12

Breast imaging

FDA-cleared K170540

DM-Density

Densitas, Inc.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2018-02-23

Breast imaging

FDA-cleared K173574

DenSeeMammo

Statlife

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2018-06-26

Breast imaging

FDA-cleared K182310

Volpara Imaging Software

Volpara Health Technologies Limited

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2018-09-21

Breast imaging

FDA-cleared K181892

Ziostation2

Ziosoft, Inc.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2018-10-09

Breast imaging

FDA-cleared K182034

Arterys MICA

Arterys Inc.

Image analysis/processing for Vascular using Mammography/DBT.

Modality: Mammography/DBT
Anatomy: Vascular
Decision: 2018-10-17

Breast imaging

FDA-cleared K181704

Transpara

ScreenPoint Medical BV

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2018-11-21

Breast imaging

FDA-cleared K182373

PowerLook Tomo Detection V2 Software

iCAD Inc.

Image analysis/processing.

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

Breast imaging

FDA-cleared K182419

Centricity Universal Viewer

GE Healthcare

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2018-12-14

Breast imaging

FDA-cleared K183285

cmTriage

CureMetrix, Inc

Image analysis/processing.

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

Breast imaging

FDA-cleared K190764

SurgicalAR

MEDIVIS, Inc.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2019-05-13

Breast imaging

FDA-cleared K183460

ClariCT.AI

ClariPI Inc.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2019-06-13

Breast imaging

FDA-cleared K190442

Koios DS for Breast

Koios Medical, Inc.

Image analysis/processing for Breast using Mammography/DBT.

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2019-07-03

Breast imaging

FDA-cleared K191994

ProFound AI Software V2.1

iCAD Inc.

Image analysis/processing.

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

Breast imaging

FDA-cleared K192455

Merge PACS

Merge Healthcare Incorporated

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2019-10-17

Breast imaging

FDA-cleared K192287

Transpara

Screenpoint Medical B.V.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2019-12-10

Breast imaging

FDA-cleared K192973

densitas densityai

Densitas, Inc.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2020-02-19

Breast imaging

FDA-cleared K193229

Transpara

ScreenPoint Medical B.V.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2020-03-05

Breast imaging

FDA-cleared K192437

Arterys MICA

Arterys Inc.

Image analysis/processing for Vascular using Mammography/DBT.

Modality: Mammography/DBT
Anatomy: Vascular
Decision: 2020-03-25

Breast imaging

FDA-cleared K192854

MammoScreen

Therapixel

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2020-03-25

Breast imaging

FDA-cleared K193220

AVIEW LCS

Coreline Soft Co., Ltd

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2020-05-05

Breast imaging

FDA-cleared K200905

HealthMammo

Zebra Medical Vision Ltd.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2020-07-16

Breast imaging

FDA-cleared K201632

TOMTEC-ARENA

TOMTEC Imaging Systems GmbH

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2020-08-14

Breast imaging

FDA-cleared K200714

AVIEW

Coreline Soft Co., Ltd

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2020-08-26

Breast imaging

FDA-cleared K202013

WRDensity by Whiterabbit.ai

Whiterabbit.ai Inc.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2020-10-30

Breast imaging

FDA-cleared K201019

Genius AI Detection

Hologic, Inc.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2020-11-18

Breast imaging

FDA-cleared K202229

AI Metrics

AI Metrics, LLC

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2020-12-22

Breast imaging

FDA-approved P200003

Imagio Breast Imaging System

Seno Medical Instruments, Inc.

Computer-aided detection/diagnosis

Modality: Modality not specified in FDA list
Anatomy: Breast
Decision: 2021-01-11

Breast imaging Detection and CADe

FDA-cleared K201411

Visage Breast Density

Visage Imaging GmbH

Image analysis/processing for Breast using Mammography/DBT.

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2021-01-29

Breast imaging

FDA-cleared K203103

Synapse 3D, Synapse 3D Base Tools v6.1

Fujifilm Corporation

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2021-02-09

Breast imaging

FDA-cleared K203822

ProFound AI Software V3.0

iCAD Inc.

Image analysis/processing.

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

Breast imaging

FDA-cleared K203517

Saige-Q

DeepHealth, Inc.

Image analysis/processing.

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

Breast imaging

FDA-cleared K210404

Transpara 1.7.0

ScreenPoint Medical B.V.

Image analysis/processing.

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

Breast imaging

FDA-cleared K211506

PowerLook Density Assessment V4.0

iCAD, Inc.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2021-07-12

Breast imaging

FDA-cleared K211279

Volpara Imaging Software

Volpara Health Technologies Limited

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2021-07-27

Breast imaging

FDA-cleared K211431

breastscape v1.0

Olea Medical

Image analysis/processing for Breast using Mammography/DBT.

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2021-08-02

Breast imaging

FDA-cleared K203785

ClariSIGMAM

ClariPi Inc.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2021-09-10

Breast imaging

FDA-cleared K212261

StrokeSENS LVO

Circle Neurovascular Imaging, Inc

Image analysis/processing for Brain using Mammography/DBT.

Modality: Mammography/DBT
Anatomy: Brain
Decision: 2021-10-14

Breast imaging

FDA-cleared K211678

Lunit INSIGHT MMG

Lunit Inc.

Image analysis/processing.

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

Breast imaging

FDA-cleared K211541

MammoScreen 2.0

Therapixel

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2021-11-26

Breast imaging

FDA-cleared K212616

Koios DS

Koios Medical, Inc.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2021-12-16

Breast imaging

FDA-cleared K210670

BU-CAD

TaiHao Medical Inc.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2021-12-21

Breast imaging

FDA-cleared K213544

TOMTEC-ARENA

TOMTEC Imaging Systems GmbH

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2022-01-06

Breast imaging

FDA-cleared K213886

BriefCase

Aidoc Medical, Ltd.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2022-04-26

Breast imaging

FDA-cleared K220105

Saige-Dx

DeepHealth, Inc.

Image analysis/processing.

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

Breast imaging

FDA-cleared K212783

ProstatID

ScanMed, LLC

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2022-07-08

Breast imaging

FDA-cleared K221347

Transpara 1.7.2

ScreenPoint Medical B.V.

Image analysis/processing.

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

Breast imaging

FDA-cleared K220080

CogNet QmTRIAGE

MedCognetics, Inc.

Image analysis/processing.

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

Breast imaging

FDA-cleared K221449

Genius AI Detection 2.0

Hologic, Inc.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2022-10-06

Breast imaging

FDA-cleared K222428

Syngo Dynamics (Version VA40F)

Siemens Medical Solutions USA, Inc.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2022-11-14

Breast imaging

FDA-cleared K221624

Avenda Health AI Prostate Cancer Planning Software

Avenda Health, Inc.

Image analysis/processing for Prostate using Mammography/DBT.

Modality: Mammography/DBT
Anatomy: Prostate
Decision: 2022-11-22

Breast imaging Prostate imaging

FDA-cleared K222275

Saige-Density

DeepHealth, Inc.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2022-12-16

Breast imaging

FDA-cleared K222174

RadioLens v1.0

Synapsica

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2023-03-28

Breast imaging

FDA-cleared K223501

ViewFinder Software Version 1.1

Elaitra Ltd

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2023-04-21

Breast imaging

FDA-cleared K230096

Genius AI Detection 2.0 with CC-MLO Correlation

Hologic, Inc.

Image analysis/processing.

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

Breast imaging

FDA-cleared K223556

DeepCatch

MEDICALIP Co., Ltd

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2023-06-16

Breast imaging

FDA-cleared K230039

uOmnispace

Shanghai United Imaging Healthcare Co., Ltd

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2023-07-20

Breast imaging

FDA-cleared K223347

UltraSight AI Guidance

UltraSight Inc.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2023-07-24

Breast imaging

FDA-cleared K232367

cmAngio® V1.0

CureMetrix, Inc.

Image analysis/processing for Vascular using Mammography/DBT.

Modality: Mammography/DBT
Anatomy: Vascular
Decision: 2023-10-05

Breast imaging

FDA-cleared K230209

Sonix Health

Ontact Health Co., Ltd.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2023-10-20

Breast imaging

FDA-cleared K231470

Lunit INSIGHT DBT

Lunit Inc.

Image analysis/processing for Breast using Mammography/DBT.

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

Breast imaging

FDA-cleared K232856

Syngo Carbon Clinicals

Siemens Healthcare GmbH

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2023-12-01

Breast imaging

FDA-cleared K232096

Transpara Density 1.0.0

Screenpoint Medical B.V.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2023-12-11

Breast imaging

FDA-cleared K231130

TumorSight Viz

SimBioSys, Inc.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2023-12-26

Breast imaging

FDA-cleared K233108

VinDr-Mammo

VinBigData Joint Stock Company

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2024-05-23

Breast imaging

FDA-cleared K240294

Syngo Carbon Enterprise Access (VA40A)

Siemens Healthcare GmbH

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2024-05-23

Breast imaging

FDA-cleared K233457

RUS

Hutom Inc.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2024-07-12

Breast imaging

FDA-cleared K240301

MammoScreen® (3)

Therapixel

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2024-08-01

Breast imaging

FDA-cleared K240697

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

See-Mode Technologies Pte. Ltd.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2024-09-09

Breast imaging

FDA-approved P140011/S008

MAMMOMAT B.brilliant with Tomosynthesis Option

SIEMENS MEDICAL SOLUTIONS USA, INC.

Computer-aided detection/diagnosis

Modality: Mammography/DBT
Anatomy: Breast
Decision: 2024-09-23

Breast imaging Detection and CADe

FDA-cleared K241561

MammoScreen BD

Therapixel

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2024-10-02

Breast imaging

FDA-cleared K242652

Lunit INSIGHT DBT v1.1

Lunit Inc.

Image analysis/processing for Breast using Mammography/DBT.

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

Breast imaging

FDA-cleared K240417

ProFound Detection (V4.0)

iCAD, Inc.

Image analysis/processing.

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

Breast imaging

FDA-cleared K242130

Koios DS

Koios Medical, Inc.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2024-11-15

Breast imaging

FDA-cleared K241747

Saige-Dx

DeepHealth, Inc

Image analysis/processing.

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

Breast imaging

FDA-cleared K241831

Transpara (2.1.0)

ScreenPoint Medical B.V.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2024-11-25

Breast imaging

FDA-cleared K242270

OrthoNext Platform System

Orthofix Srl

Image analysis/processing.

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

Breast imaging

FDA-cleared K243688

Saige-Dx (3.1.0)

DeepHealth, Inc.

Image analysis/processing.

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

Breast imaging

FDA-cleared K243705

Saige-Density (2.5.0)

DeepHealth, Inc

Image analysis/processing.

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

Breast imaging

FDA-cleared K242362

Lightning Viewer

Nexsys Electronics Inc. dba Medweb

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2024-12-20

Breast imaging

FDA-cleared K243065

Cardiac Guidance

Caption Health, Inc.

Image analysis/processing for Heart using Mammography/DBT.

Modality: Mammography/DBT
Anatomy: Heart
Decision: 2025-01-15

Breast imaging Cardiac imaging

FDA-cleared K242838

QuickRad

Aikenist Technologies Pvt Ltd

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2025-02-21

Breast imaging

FDA-cleared K241770

Prostate MR AI (VA10A)

Siemens Healthcare GmbH

Image analysis/processing for Prostate using Mammography/DBT.

Modality: Mammography/DBT
Anatomy: Prostate
Decision: 2025-03-05

Breast imaging Prostate imaging

FDA-cleared K242683

QP-Prostate® CAD

Quibim S.L.

Image analysis/processing for Prostate using Mammography/DBT.

Modality: Mammography/DBT
Anatomy: Prostate
Decision: 2025-03-18

Breast imaging Prostate imaging

FDA-cleared K242551

syngo Dynamics (Version VA41D)

Siemens Healthcare GmbH

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2025-04-03

Breast imaging

FDA-cleared K242807

HeartFocus (V.1.1.1)

Deski

Image analysis/processing for Heart using Mammography/DBT.

Modality: Mammography/DBT
Anatomy: Heart
Decision: 2025-04-04

Breast imaging Cardiac imaging

FDA-cleared K250754

cmAngio® (V1.6)

CureMetrix, Inc.

Image analysis/processing for Vascular using Mammography/DBT.

Modality: Mammography/DBT
Anatomy: Vascular
Decision: 2025-04-10

Breast imaging

FDA-cleared K243651

VersaViewer

GE Medical Systems SCS

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2025-04-21

Breast imaging

FDA-cleared K243762

Synapse 3D Base Tools (V7.0)

FUJIFILM Corporation

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2025-05-21

Breast imaging

FDA-cleared K243647

Synapse PACS (7.5)

FUJIFILM Healthcare Americas Corporation

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2025-06-30

Breast imaging

FDA-cleared K243679

MammoScreen® (4)

Therapixel

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2025-07-03

Breast imaging

FDA-cleared K243341

Genius AI Detection 2.0

Hologic, Inc.

Image analysis/processing.

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

Breast imaging

FDA-cleared K251873

Saige-Dx

DeepHealth, Inc.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2025-08-11

Breast imaging

FDA-cleared K243685

MammoScreen BD

Therapixel

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2025-08-22

Breast imaging

FDA-cleared K252539

Tempus Pixel

Arterys, Inc.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2025-09-03

Breast imaging

FDA-cleared K250237

InferOperate Suite

Beijing Infervision Healthcare Medical Technology Co., Ltd.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2025-09-15

Breast imaging

FDA-cleared K251059

Syngo Carbon Clinicals (VA41)

Siemens Healthineers AG

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2025-10-24

Breast imaging

FDA-cleared K250330

3mensio Workstation

Pie Medical Imaging BV

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2025-11-03

Breast imaging

FDA-cleared K252482

CogNet AI-MT+

Medcognetics, Inc.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2025-12-11

Breast imaging

FDA-cleared K251416

UltraSight Guidance

Ultrasight , Ltd.

Image analysis/processing.

Modality: Mammography/DBT
Anatomy: N/A
Decision: 2025-12-17

Breast imaging