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.

AEYE-DS

K240058

AEYE Health Inc.

PIB · Ophthalmic · 2024-04-23

ART-Plan (v.2.2.0)

K234068

Therapanacea SAS

MUJ · Radiology · 2024-04-22

Rapid

K233582

iSchema View Inc.

LLZ · Radiology · 2024-04-22

SKOUT® system

K240781

Iterative Scopes, Inc.

QNP · Gastroenterology-Urology · 2024-04-19

uOmnispace.MR

K233186

Shanghai United Imaging Healthcare Co., Ltd.

QIH · Radiology · 2024-04-17

VisAble.IO

K240773

Techsomed

QTZ · Radiology · 2024-04-15

Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR

K240238

Canon Medical Systems Corporation

LNH · Radiology · 2024-04-12

True Enhance DL

K233698

GE Healthcare Japan Corporation

JAK · Radiology · 2024-04-11

uMR 680

K240744

Shanghai United Imaging Healthcare Co., Ltd.

LNH · Radiology · 2024-04-10

Rho

DEN230023

16 Bit Inc

SAO · Radiology · 2024-04-09

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

K240291

Ever Fortune.AI, Co., Ltd.

QAS · Radiology · 2024-04-08

CorVista System with PH Add-On

K233666

Analytics for Life, Inc.

SAT · Cardiovascular · 2024-04-05

APPRAISE-HRI

K233249

The Surgeon General, Department of the Army (TSG-DA)

SAR · Cardiovascular · 2024-04-05

Preview Shoulder

K240172

Genesis Software Innovations

QIH · Radiology · 2024-04-04

Oxevision Sleep Device

K233618

Oxehealth Limited

LEL · Neurology · 2024-04-03

AI-Rad Companion Organs RT

K232899

Siemens Medical Solutions U.S.A.

QKB · Radiology · 2024-04-03

Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System

K232835

Canon Medical Systems Corporation

JAK · Radiology · 2024-04-02

Sepsis ImmunoScore

DEN230036

Prenosis, Inc.

SAK · General Hospital · 2024-04-02

Us2.v2

K233676

Eko.ai Pte. Ltd d/b/a Us2.ai

QIH · Radiology · 2024-04-01

AVIEW CAC

K233211

Coreline Soft Co., Ltd.

QIH · Radiology · 2024-03-29

NAEOTOM Alpha

K233657

Siemens Medical Solutions USA, Inc.

JAK · Radiology · 2024-03-28

Eko Low Ejection Fraction Tool (ELEFT)

K233409

Eko Health, Inc.

QYE · Cardiovascular · 2024-03-28

SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed

K233650

Siemens Medical Solutions USA, Inc.

JAK · Radiology · 2024-03-26

uMR Omega

K240540

Shanghai United Imaging Healthcare Co., Ltd.

LNH · Radiology · 2024-03-22

syngo.CT Brain Hemorrhage

K232431

Siemens Medical Solutions USA, Inc.

QAS · Radiology · 2024-03-22

MAGNETOM Terra; MAGNETOM Terra.X

K232322

Siemens Medical Solutions USA, Inc.

LNH · Radiology · 2024-03-22

AI-Rad Companion (Pulmonary)

K233753

Siemens Healthcare GmbH

JAK · Radiology · 2024-03-21

Automatic Registration

K234047

Brainlab AG

OLO · Neurology · 2024-03-20

CINA-ASPECTS

K233342

Avicenna.AI

POK · Radiology · 2024-03-15

CINA-iPE

K233968

Avicenna.AI

QAS · Radiology · 2024-03-13

OTS Hip

K232140

Ortoma AB

OLO · Neurology · 2024-03-11

SleepStageML

K233438

Beacon Biosignals, Inc.

OLZ · Neurology · 2024-03-08

Voluson Signature 20, Voluson Signature 18

K233692

GE Medical Systems Ultrasound and Primary care Diagnostics,

IYN · Radiology · 2024-03-07

EdgeFlow UH10

K231677

Edgecare Inc.

IYO · Radiology · 2024-03-06

Overjet Caries Assist-Pediatric

K233738

Overjet, Inc

MYN · Radiology · 2024-03-04

BoneMRI

K233030

MRIguidance B.V

QIH · Radiology · 2024-03-01

iCAS-LV

K231690

HighRAD Ltd.

QIH · Radiology · 2024-03-01

MAGNETOM Cima.X Fit

K232765

Siemens Medical Solutions USA, Inc.

LNH · Radiology · 2024-02-29

inHEART Models

K231683

inHEART, SAS

QIH · Radiology · 2024-02-29

CT Cardiomegaly

K232613

Innolitics, LLC

QIH · Radiology · 2024-02-28

Overjet Charting Assist

K233590

Overjet, Inc

QIH · Radiology · 2024-02-23

Revolution Ascend Sliding

K233749

GE Hangwei Medical Systems Co., Ltd.

JAK · Radiology · 2024-02-22

X-Guide Surgical Navigation System

K232148

X-Nav Technologies, LLC

QRY · Dental · 2024-02-21

EpiMonitor

K232915

Empatica Srl

POS · Neurology · 2024-02-15

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

K233788

Philips Ultrasound LLC

IYN · Radiology · 2024-02-13

QOCA® image Smart RT Contouring System

K231855

Quanta Computer Inc.

QKB · Radiology · 2024-02-13

Aurora

K231355

EnsoData

MNR · Anesthesiology · 2024-02-09

HealthFLD

K233080

Nano-X AI Ltd.

JAK · Radiology · 2024-02-08

Sleep Apnea Feature

DEN230041

Samsung Electronics Co., Ltd

QZW · Anesthesiology · 2024-02-06

Viz HDS, Viz Volume Plus, Viz ICH+

K232363

Viz.ai, Inc.

QIH · Radiology · 2024-02-05

CEPHX- Cephalometric Analysis Software

K231396

Orca Dental AI LTD

LLZ · Radiology · 2024-01-31

Genius Digital Diagnostics System with the Genius Cervical AI algorithm

DEN210035

Hologic Inc.

QYV · Pathology · 2024-01-31

Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System

K233195

Canon Medical Systems Corporation

IYN · Radiology · 2024-01-24

SIGNA Champion

K233728

GE Healthcare (Tianjin) Company Limited

LNH · Radiology · 2024-01-19

Rapid ASPECTS (v3)

K232156

iSchemaView, Inc.

POK · Radiology · 2024-01-19

NemoScan

K232698

Software Nemotec S.L.

QIH · Radiology · 2024-01-18

Radify Triage

K231871

Envisionit DeepAI Ltd

QFM · Radiology · 2024-01-17

Rapid (6.0)

K233512

iSchemaView, Inc.

QIH · Radiology · 2024-01-16

CLEWICU System

K233216

Clew Medical Ltd.

QNL · Cardiovascular · 2024-01-13

GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)

K233964

Cosmo Artificial Intelligence - AI Ltd

QNP · Gastroenterology-Urology · 2024-01-12

Biograph VK10

K233677

Siemens Medical Solutions USA, Inc.

KPS · Radiology · 2024-01-12

DermaSensor

DEN230008

DermaSensor Inc.

QZS · General and Plastic Surgery · 2024-01-12

Fibresolve

DEN220040

Imvaria, Inc

QWO · Radiology · 2024-01-12

SurgiCount+ System

K232250

Stryker Instruments

PBZ · General Hospital · 2024-01-11

BrainSee

DEN220066

Darmiyan, Inc.

QWT · Neurology · 2024-01-11

LungQ v3.0.0

K232412

Thirona BV

JAK · Radiology · 2024-01-08

DASI Dimensions (V1.0)

K231324

DASI Simulations

QIH · Radiology · 2024-01-08

autoSCORE

K231068

Holberg EEG AS

OMB · Neurology · 2024-01-07

VEA Align

K231917

EOS imaging

QIH · Radiology · 2024-01-05

Butterfly iQ3 Ultrasound System

K232808

Butterfly Network, Inc.

IYN · Radiology · 2024-01-04

REMI AI Discrete Detection Module

K231779

Epitel, Inc.

OMB · Neurology · 2024-01-03

TumorSight Viz

K231130

SimBioSys, Inc.

QIH · Radiology · 2023-12-26

MAGNETOM Sola; MAGNETOM Altea

K232535

Siemens Medical Solutions USA, Inc.

LNH · Radiology · 2023-12-22

ART-Plan

K232479

TheraPanacea

MUJ · Radiology · 2023-12-22

qXR-LN

K231805

Qure.ai Technologies

MYN · Radiology · 2023-12-22

HM70 EVO Diagnostic Ultrasound System

K233112

Samsung Medison CO., LTD.

IYN · Radiology · 2023-12-21

uOmnispace.MI

K233176

Shanghai United Imaging Healthcare Co., Ltd.

LLZ · Radiology · 2023-12-20

United Orthopedic Knee Patient Specific Instrumentation

K230850

Enhatch, Inc.

OOG · Orthopedic · 2023-12-20

iQ-solutions

K231929

Sydney Neuroimaging Analysis Centre Pty Ltd

QIH · Radiology · 2023-12-18

MAGNETOM Cima.X

K231587

Siemens Medical Solutions USA, Inc.

LNH · Radiology · 2023-12-18

Videa Dental Assist

K232384

VideaHealth, Inc.

MYN · Radiology · 2023-12-15

EW10-EC02 Endoscopy Support Program

K230751

FUJIFILM Corporation

QNP · Gastroenterology-Urology · 2023-12-15

StrokeViewer Perfusion

K231570

NICo-Lab B.V.

LLZ · Radiology · 2023-12-14

Tyto Insights for Wheeze Detection

K232237

Tyto Care Ltd.

PHZ · Anesthesiology · 2023-12-13

QP-Brain®

K232231

Quibim S.L.

QIH · Radiology · 2023-12-13

NaviCam ProScan

DEN230027

Ankon Technologies co., ltd

QZF · Gastroenterology-Urology · 2023-12-12

Transpara Density 1.0.0

K232096

Screenpoint Medical B.V.

QIH · Radiology · 2023-12-11

DTX Studio Clinic (4.0)

K231898

Nobel Biocare AB

LLZ · Radiology · 2023-12-08

Bonelogic

K223757

Disior Ltd

LLZ · Radiology · 2023-12-08

Myocardial Strain Software Application

K232661

Circle Cardiovascular Imaging

LLZ · Radiology · 2023-12-07

LOGIQ Totus

K232381

GE Medical Systems Ultrasound and Primary care Diagnostics,

IYN · Radiology · 2023-12-07

LINQ II Insertable Cardiac Monitor

K233562

Medtronic, Inc.

MXD · Cardiovascular · 2023-12-06

Aquilion Serve SP (TSX-307B/1) V1.3

K233334

Canon Medical Systems Corporation

JAK · Radiology · 2023-12-06

Ceevra Reveal 3+

K233568

Ceevra, Inc.

QIH · Radiology · 2023-12-05

Adravision Perio

K232440

Adra Corporation

QIH · Radiology · 2023-12-05

Syngo Carbon Clinicals

K232856

Siemens Healthcare GmbH

QIH · Radiology · 2023-12-01

EPIQ Series Diagnostic Ultrasound System

K233545

Philips Ultrasound LLC

IYN · Radiology · 2023-11-30

6440 MyLabX90

K230179

Esaote S.p.A.

IYN · Radiology · 2023-11-29

syngo.via MI Workflows; Scenium; syngo MBF

K232000

Siemens Medical Solutions USA, Inc.

QIH · Radiology · 2023-11-28

BriefCase-Quantification

K231631

Aidoc Medical, Ltd.

JAK · Radiology · 2023-11-28

AEYE-DS

ART-Plan (v.2.2.0)

Rapid

SKOUT® system

uOmnispace.MR

VisAble.IO

Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR

True Enhance DL

uMR 680

Rho

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

CorVista System with PH Add-On

APPRAISE-HRI

Preview Shoulder

Oxevision Sleep Device

AI-Rad Companion Organs RT

Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System

Sepsis ImmunoScore

Us2.v2

AVIEW CAC

NAEOTOM Alpha

Eko Low Ejection Fraction Tool (ELEFT)

SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed

uMR Omega

syngo.CT Brain Hemorrhage

MAGNETOM Terra; MAGNETOM Terra.X

AI-Rad Companion (Pulmonary)

Automatic Registration

CINA-ASPECTS

CINA-iPE

OTS Hip

SleepStageML

Voluson Signature 20, Voluson Signature 18

EdgeFlow UH10

Overjet Caries Assist-Pediatric

BoneMRI

iCAS-LV

MAGNETOM Cima.X Fit

inHEART Models

CT Cardiomegaly

Overjet Charting Assist

Revolution Ascend Sliding

X-Guide Surgical Navigation System

EpiMonitor

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

QOCA® image Smart RT Contouring System

Aurora

HealthFLD

Sleep Apnea Feature

Viz HDS, Viz Volume Plus, Viz ICH+

CEPHX- Cephalometric Analysis Software

Genius Digital Diagnostics System with the Genius Cervical AI algorithm

Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System

SIGNA Champion

Rapid ASPECTS (v3)

NemoScan

Radify Triage

Rapid (6.0)

CLEWICU System

GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)

Biograph VK10

DermaSensor

Fibresolve

SurgiCount+ System

BrainSee

LungQ v3.0.0

DASI Dimensions (V1.0)

autoSCORE

VEA Align

Butterfly iQ3 Ultrasound System

REMI AI Discrete Detection Module

TumorSight Viz

MAGNETOM Sola; MAGNETOM Altea

ART-Plan

qXR-LN

HM70 EVO Diagnostic Ultrasound System

uOmnispace.MI

United Orthopedic Knee Patient Specific Instrumentation

iQ-solutions

MAGNETOM Cima.X

Genius Digital Diagnostics System with the Genius Cervical AI algorithm

GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)