FDA AI/ML clearance directory

Browse source-quoted 510(k) and De Novo evidence

One crawlable directory over Constat's FDA AI/ML device evidence records, newest clearance decisions first. Open a device for validation studies, reported metrics, predicate context, postmarket signals, reimbursement links, and FDA source quotes.

Clever One

K250005

Ewoosoft Co., Ltd

QIH · Radiology · 2025-05-23

Second Opinion® 3D

K243989

Pearl, Inc.

QIH · Radiology · 2025-05-23

Accuro 3S

K243937

Rivanna Medical, Inc.

IYO · Radiology · 2025-05-23

DEEPECHO

K242594

DeepEcho

IYN · Radiology · 2025-05-23

Swoop® Portable MR Imaging® System

K251276

Hyperfine, Inc.

LNH · Radiology · 2025-05-21

InVision Precision Cardiac Amyloid

K243866

InVision Medical Technology Corporation

SDJ · Cardiovascular · 2025-05-21

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

K243793

Philips Ultrasound LLC

IYN · Radiology · 2025-05-21

Synapse 3D Base Tools (V7.0)

K243762

FUJIFILM Corporation

QIH · Radiology · 2025-05-21

uMR Omega

K243122

Shanghai United Imaging Healthcare Co., Ltd.

LNH · Radiology · 2025-05-21

SCENARIA View Phase 5.0

K250370

FUJIFILM Corporation

JAK · Radiology · 2025-05-20

OTS Hip

K250086

Ortoma AB

OLO · Neurology · 2025-05-16

uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis

K243617

Shanghai United Imaging Healthcare Co.,Ltd.

JAK · Radiology · 2025-05-16

6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)

K241671

Esaote S.p.A.

IYN · Radiology · 2025-05-16

InferRead Lung CT.AI

K240554

Infervision Medical Technology Co., Ltd.

OEB · Radiology · 2025-05-16

Medical Image Post-processing Software (uOmnispace.CT)

K242624

Shanghai United Imaging Healthcare Co., Ltd.

QIH · Radiology · 2025-05-14

Smile Dx®

K242437

Cube Click, Inc.

MYN · Radiology · 2025-05-14

SKOUT system

K251126

Iterative Health

QNP · Gastroenterology-Urology · 2025-05-09

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

K251110

Philips Ultrasound LLC

IYN · Radiology · 2025-05-09

Volta AF-Xplorer

K243812

Volta Medical

DQK · Cardiovascular · 2025-05-09

Second Opinion® BLE

K243230

Pearl Inc.

QIH · Radiology · 2025-05-09

LensHooke X12 PRO Semen Analysis System

K242388

Bonraybio Co., LTD.

POV · Hematology · 2025-05-09

Clarius Median Nerve AI

K250226

Clarius Mobile Health Corp.

QIH · Radiology · 2025-05-08

BrightHeart View Classifier

K243684

BrightHeart

QIH · Radiology · 2025-05-07

Second Opinion® Pediatric

K243893

Pearl, Inc.

MYN · Radiology · 2025-05-05

Fetal EchoScan (v1.1)

K251071

BrightHeart

POK · Radiology · 2025-05-02

AT-Patch (ATP-C130/ATP-C70)

K242583

ATsens Co.,Ltd.

DSH · Cardiovascular · 2025-05-02

Vscan Air

K250087

GE Medical Systems Ultrasound and Primary Care Diagnostics

IYN · Radiology · 2025-05-01

UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program

K250328

Canon Medical Systems Corporation

QIH · Radiology · 2025-04-30

uAngio AVIVA CX

K243376

Shanghai United Imaging Healthcare Co.,Ltd.

OWB · Radiology · 2025-04-28

Lung AI (LAI001)

K243239

Exo Inc

MYN · Radiology · 2025-04-24

Annalise Enterprise

K250831

Annalise-AI

QFM · Radiology · 2025-04-23

VersaViewer

K243651

GE Medical Systems SCS

LLZ · Radiology · 2025-04-21

CLARUS (700)

K243878

Carl Zeiss Meditec, Inc.

QER · Ophthalmic · 2025-04-17

VitalRhythm

K242129

VitalConnect, Inc.

DQK · Cardiovascular · 2025-04-17

Clarius Prostate AI

K243853

Clarius Mobile Health Corp.

QIH · Radiology · 2025-04-16

LARALAB

K242500

LARALAB GmbH

QIH · Radiology · 2025-04-16

SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option

K250650

Arineta Ltd.

JAK · Radiology · 2025-04-15

GBrain MRI

K250416

Galileo CDS, Inc

QIH · Radiology · 2025-04-11

Canvas Dx

K243558

Cognoa, Inc.

QPF · Neurology · 2025-04-11

Oncospace

K242748

Oncospace, Inc.

MUJ · Radiology · 2025-04-11

Second Opinion Periapical Radiolucency Contours

K242600

Pearl Inc.

MYN · Radiology · 2025-04-11

cmAngio® (V1.6)

K250754

CureMetrix, Inc.

QIH · Radiology · 2025-04-10

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

K250177

Philips Ultrasound LLC

IYN · Radiology · 2025-04-10

syngo.CT LVO Detection

K243145

Siemens Medical Solutions USA, Inc.

QAS · Radiology · 2025-04-10

autoSCORE (V 2.0.0)

K243743

Holberg EEG AS

OMB · Neurology · 2025-04-09

BunkerHill BMD

K242295

BunkerHill Health

KGI · Radiology · 2025-04-08

Tyto Insights for Rhonchi Detection

K243567

Tyto Care , Ltd.

PHZ · Anesthesiology · 2025-04-07

QFR (3.0)

K243769

QFR Solutions bv

QHA · Radiology · 2025-04-04

HeartFocus (V.1.1.1)

K242807

Deski

QJU · Radiology · 2025-04-04

DeepFoqus (DeepFoqus-Accelerate)

K241982

Foqus Technologies Inc.

QIH · Radiology · 2025-04-04

RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3

K240398

RaySearch Laboratories AB (PUBL)

MUJ · Radiology · 2025-04-04

syngo Dynamics (Version VA41D)

K242551

Siemens Healthcare GmbH

QIH · Radiology · 2025-04-03

Hi-D Imaging 4TAVR

K241984

Hi-D Imaging AG

QIH · Radiology · 2025-04-02

MR Contour DL

K242925

GE HealthCare

QKB · Radiology · 2025-04-01

TribusConnect

K242166

TribusMed Beheer BV

QIH · Radiology · 2025-03-31

Salix Central

K243038

Artrya Limited

QIH · Radiology · 2025-03-27

V5med Lung AI

K242919

V5med Inc.

OEB · Radiology · 2025-03-27

AI-Rad Companion Organs RT

K242745

Siemens Healthcare GmbH

QKB · Radiology · 2025-03-27

EarliPoint System

K243891

EarliTec Diagnostics

QPF · Neurology · 2025-03-26

Rayvolve LN

K243831

AZmed

MYN · Radiology · 2025-03-26

GoLIF! Lumbar Interbody Fusion System

K250186

GetSet Surgical, SA

MAX · Orthopedic · 2025-03-21

Rayvolve PTX-PE

K243808

AZmed

QFM · Radiology · 2025-03-21

brAIn™ Shoulder Positioning

K243292

Avatar Medical

LLZ · Radiology · 2025-03-20

Vent Creativity Knee v1.0 (Hermes)

K241961

Vent Creativity

QIH · Radiology · 2025-03-20

PeekMed web

K250042

Peek Health, S.A.

QIH · Radiology · 2025-03-19

AVIEW

K243689

Coreline Soft Co., Ltd.

QIH · Radiology · 2025-03-19

QP-Prostate® CAD

K242683

Quibim S.L.

QDQ · Radiology · 2025-03-18

SIGNA Prime Elite

K250379

GE Medical Systems, LLC

LNH · Radiology · 2025-03-17

LVivo Software Application

K243862

DiA Imaging Analysis Ltd.

QIH · Radiology · 2025-03-17

Maestro System (REF100)

K242323

Moon Surgical

QZB · Gastroenterology-Urology · 2025-03-14

DeepRESP

K241960

Nox Medical ehf

OLZ · Neurology · 2025-03-14

xvision Spine system

K250255

Augmedics Ltd.

SBF · Neurology · 2025-03-13

Better Diagnostics Caries Assist (BDCA) Version 1.0

K241725

Better Diagnostics AI Corp

MYN · Radiology · 2025-03-11

Cleerly LABS (v2.0)

K242338

Cleerly, Inc.

QIH · Radiology · 2025-03-07

LVivo Seamless

K243331

DiA Imaging Analysis Ltd.

QIH · Radiology · 2025-03-06

Prostate MR AI (VA10A)

K241770

Siemens Healthcare GmbH

QDQ · Radiology · 2025-03-05

Ceevra Reveal 3+

K243933

Ceevra, Inc.

QIH · Radiology · 2025-03-04

JLK-SDH

K243611

JLK, Inc.

QAS · Radiology · 2025-03-03

LVivo Software Application

K243235

DiA Imaging Analysis Ltd.

QIH · Radiology · 2025-03-03

Airmod

K242798

Heroic Faith International Ltd.

BZQ · Anesthesiology · 2025-02-28

Myomics

K241922

Phantomics Inc.

QIH · Radiology · 2025-02-28

ChestView US

K241620

Gleamer SAS

MYN · Radiology · 2025-02-27

aiCockpit AI Viewer

K241546

Fovia, Inc.

LLZ · Radiology · 2025-02-26

Ventripoint Medical System Plus (VMS+) 4.0

K241222

Ventripoint Diagnostics Ltd.

QIH · Radiology · 2025-02-26

3DXR

K243446

GE Medical Systems SCS

OWB · Radiology · 2025-02-25

Loss of Pulse Detection

K242967

Fitbit

SDY · Cardiovascular · 2025-02-25

ART-Plan+ (v.3.0.0)

K242822

Therapanacea SAS

MUJ · Radiology · 2025-02-25

OncoStudio (OS-01)

K242994

OncoSoft. Co., Ltd.

QKB · Radiology · 2025-02-24

Sonio Suspect

K243614

Sonio

POK · Radiology · 2025-02-21

QuickRad

K242838

Aikenist Technologies Pvt Ltd

LLZ · Radiology · 2025-02-21

ScanDiags Ortho L-Spine MR-Q

K242607

ScanDiags AG

QIH · Radiology · 2025-02-21

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

K242821

Ever Fortune.AI, Co., Ltd.

QAS · Radiology · 2025-02-20

Falcon HST

K242447

Compumedics Limited

OLV · Neurology · 2025-02-20

CaRi-Plaque

K242240

Caristo Diagnostics Ltd.

LLZ · Radiology · 2025-02-20

BriefCase-Triage

K250248

Aidoc Medical, Ltd.

QAS · Radiology · 2025-02-14

AVIEW CAC

K243696

Coreline Soft Co., Ltd.

QIH · Radiology · 2025-02-14

Brainomix 360 e-ASPECTS

K243294

Brainomix Limited

POK · Radiology · 2025-02-14

V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System

K243702

Samsung Medison Co., Ltd.

IYN · Radiology · 2025-02-12

NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime

K243523

Siemens Medical Solutions USA, Inc.

JAK · Radiology · 2025-02-12

SubtleHD (1.x)

K243250

Subtle Medical, Inc.

QIH · Radiology · 2025-02-12

Statistical pattern analysis of public FDA / CMS data — descriptive decision-support, not legal, regulatory, coding, or reimbursement advice. Verify against primary sources. A Health AI product · machine access over MCP · terms & dataset license.