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.

Corvair Monza

K252589

AliveCor, Inc.

MHX · Cardiovascular · 2026-01-09

LOGIQ Totus

K253370

GE Medical Systems Ultrasound and Primary Care Diagnostics

IYN · Radiology · 2026-01-08

LOGIQ Fortis

K253366

GE Medical Systems Ultrasound and Primary Care Diagnostics

IYN · Radiology · 2026-01-07

DS Core Detect

K253009

Dentsply Sirona, Inc.

MYN · Radiology · 2026-01-07

BriefCase-Triage: CARE Multi-triage CT Body

K252970

Aidoc Medical , Ltd.

QAS · Radiology · 2026-01-07

HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System

K252018

Samsung Medison Co., Ltd.

IYN · Radiology · 2026-01-05

TruSPECT Processing Station

K253532

Spectrum Dynamics Medical, Ltd.

QIH · Radiology · 2025-12-30

ART-Plan+ (v3.1.0)

K253091

Therapanacea Sas

MUJ · Radiology · 2025-12-23

AIR Recon DL

K252379

Ge Medical Systems, LLC

LNH · Radiology · 2025-12-23

SKOUT system

K253664

Iterative Health

QNP · Gastroenterology-Urology · 2025-12-22

PeekMed web

K252856

Peek Health, S.A.

QIH · Radiology · 2025-12-22

Lumify Diagnostic Ultrasound System

K252557

Philips Ultrasound, LLC

IYN · Radiology · 2025-12-22

BioticsAI

K250959

Bioticsai, Inc.

IYN · Radiology · 2025-12-22

MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise

K252838

Siemens Healthcare GmbH

LNH · Radiology · 2025-12-19

Alzevita

K252670

TOPIA MEDTECH LIMITED

QIH · Radiology · 2025-12-19

eMurmur Heart AI

K252284

Csd Labs

DQD · Cardiovascular · 2025-12-19

AI-CVD

K252029

HeartLung Corporation

QIH · Radiology · 2025-12-19

Assert-IQ (DM5100)

K253516

Abbott Medical

MXD · Cardiovascular · 2025-12-18

PVAD IQ Software

K252235

Ultrasight , Ltd.

QIH · Radiology · 2025-12-18

MediAI-BA

K250914

Crescom Co., Ltd.

QIH · Radiology · 2025-12-18

Neosoma Brain Mets

K252922

Neosoma, Inc.

QIH · Radiology · 2025-12-17

UltraSight Guidance

K251416

Ultrasight , Ltd.

QJU · Radiology · 2025-12-17

prolaio eVO2peak Module (Version 1.0)

K252204

Prolaio, Inc.

PPW · Cardiovascular · 2025-12-16

IRISeg

K251763

Intuitive Surgical, Inc.

QIH · Radiology · 2025-12-16

Swoop® Portable MR Imaging® System

K253489

Hyperfine, Inc.

LNH · Radiology · 2025-12-12

DeepRhythmAI

K253141

Medicalgorithmics S.A.

DQK · Cardiovascular · 2025-12-11

CogNet AI-MT+

K252482

Medcognetics, Inc.

QFM · Radiology · 2025-12-11

SANSA HSAT

K252497

Huxley Medical

MNR · Anesthesiology · 2025-12-10

INFINITT DPS

K243449

Infinitt Healthcare Co., Ltd.

QKQ · Pathology · 2025-12-09

Fetal EchoScan (v1.2)

K252294

Brightheart

POK · Radiology · 2025-12-08

Ceribell Delirium Monitor System

K251936

Ceribell, Inc.

NCG · Neurology · 2025-12-08

Gastric Alimetry

K252504

Alimetry , Ltd.

MYE · Gastroenterology-Urology · 2025-12-05

Personalized Therapy Comfort Settings (PTCS)

K251657

ResMed Corp

BZD · Anesthesiology · 2025-12-05

Overjet CBCT Assist

K251514

Overjet, Inc.

QIH · Radiology · 2025-12-05

ARTAssistant

K250780

Manteia Technologies Co., Ltd.

QKB · Radiology · 2025-12-05

AVIEW Lung Nodule CAD

K251203

Coreline Soft Co.,Ltd

OEB · Radiology · 2025-12-03

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

K252103

Mighty Oak Medical

QIH · Radiology · 2025-12-02

Cartesion Prime (PCD-1000A/3) V10.21

K251370

Canon Medical Systems Corporation

KPS · Radiology · 2025-12-01

CT VScore+

K252217

Canon Medical Informatics, Inc.

JAK · Radiology · 2025-11-28

OEC One CFD

K253269

Ge Hualun Medical Systems Co. , Ltd.

OXO · Radiology · 2025-11-26

7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)

K253310

Esaote, S.P.A.

IYN · Radiology · 2025-11-25

Scaida BrainCT-ICH (v1.0)

K250694

Mlhealth 360

QAS · Radiology · 2025-11-25

a2z-Unified-Triage

K252366

A2z Radiology Ai, Inc.

QAS · Radiology · 2025-11-24

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

K252328

Ge Medical Systems Ultrasound and Primary Care Diagnostics

IYN · Radiology · 2025-11-24

Nelli (Version 7.11)

K251506

Neuro Event Labs OY

POS · Neurology · 2025-11-21

CardioVision

K251293

Icardio.Ai

QUO · Cardiovascular · 2025-11-21

MAGNETOM Free.Max; MAGNETOM Free.Star

K251822

Siemens Shenzhen Magnetic Resonance , Ltd.

LNH · Radiology · 2025-11-20

DeepRESP

K252330

Nox Medical Ehf

OLZ · Neurology · 2025-11-17

DTX Studio Assist

K252086

Nobel Biocare C/O Medicim NV

MYN · Radiology · 2025-11-17

AutoDensity

K251078

Eos Imaging

QIH · Radiology · 2025-11-14

Second Opinion® Panoramic

K250525

Pearl, Inc.

MYN · Radiology · 2025-11-14

PeekMed web

K252452

Peek Health, S.A.

QIH · Radiology · 2025-11-12

Fibresolve (with PCCP)

K252041

Imvaria, Inc.

QWO · Radiology · 2025-11-07

SugarBug (1.x)

K250264

Bench7, Inc.

MYN · Radiology · 2025-11-07

BriefCase-Triage

K253265

Aidoc Medical , Ltd.

QAS · Radiology · 2025-11-06

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

K251532

Mighty Oak Medical

LLZ · Radiology · 2025-11-03

3mensio Workstation

K250330

Pie Medical Imaging BV

QIH · Radiology · 2025-11-03

Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System

K252074

Canon Medical Systems Corporation

IYN · Radiology · 2025-10-31

AiORTA - Plan

K250337

ViTAA Medical Solutions, Inc.

QIH · Radiology · 2025-10-30

LOGIQ E10

K251985

Ge Medical Systems Ultrasound and Primary Care Diagnostics

IYN · Radiology · 2025-10-29

LOGIQ E10s

K251963

Ge Medical Systems Ultrasound and Primary Care Diagnostics

IYN · Radiology · 2025-10-29

SANSA HSAT

K250882

Huxley Medical

MNR · Anesthesiology · 2025-10-29

cvi42 Coronary Plaque Software Application

K251027

Circle Cardiovascular Imaging, Inc.

QIH · Radiology · 2025-10-27

Syngo Carbon Clinicals (VA41)

K251059

Siemens Healthineers AG

QIH · Radiology · 2025-10-24

TeraRecon Cardiovascular.Calcification.CT

K250288

Terarecon,Inc.

QIH · Radiology · 2025-10-23

ANDI 2.0

K252298

Imeka Solutions, Inc.

QIH · Radiology · 2025-10-22

brAIn Shoulder Positioning

K252665

Avatar Medical

QIH · Radiology · 2025-10-20

X9 Ultrasound System

K251673

X9, Inc.

SGH · Radiology · 2025-10-17

X1-FFR

K251355

Spectrawave, Inc.

QHA · Radiology · 2025-10-17

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging

K251602

Canon Medical Systems Corporation

OWB · Radiology · 2025-10-10

HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)

K251082

Procept Biorobotics

PZP · General and Plastic Surgery · 2025-10-10

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

K251651

Philips Ultrasound, LLC

IYN · Radiology · 2025-10-09

AIAS Cephalon

K252214

Metamorphosis GmbH

QIH · Radiology · 2025-10-07

BlineSlide

K252007

Deep Breathe, Inc.

QIH · Radiology · 2025-10-06

MAGENTIQ-COLO (ME-APDS)

K252178

Magentiq Eye, Ltd.

QNP · Gastroenterology-Urology · 2025-10-03

xvision Spine system

K251639

Augmedics, Ltd.

SBF · Neurology · 2025-10-03

Bunkerhill MAC

K250662

Bunkerhill Health

JAK · Radiology · 2025-10-03

LungQ 4

K250766

Thirona BV

JAK · Radiology · 2025-10-02

SpineAR SNAP (SyncAR Spine)

K252054

Surgical Theater, Inc.

SBF · Neurology · 2025-09-29

SMART PCFD

K250023

Disior Ltd

QIH · Radiology · 2025-09-29

Ligence Heart

K252105

Ligence, UAB

QIH · Radiology · 2025-09-26

uMR 680

K252371

Shanghai United Imaging Healthcare Co., Ltd.

LNH · Radiology · 2025-09-25

Brain WMH

K251527

Quantib BV

QIH · Radiology · 2025-09-25

Rapid Aortic Measurements

K251987

iSchemaView, Inc.

QIH · Radiology · 2025-09-23

SwiftSight-Brain

K251483

AIRS Medical Inc.

QIH · Radiology · 2025-09-23

uDR Aurora CX

K251167

Shanghai United Imaging Healthcare Co., Ltd.

KPR · Radiology · 2025-09-19

Videa Dental AI

K251002

VideaHealth Inc.

MYN · Radiology · 2025-09-19

Bunkerhill ECG-EF

K250649

BunkerHill Health

QYE · Cardiovascular · 2025-09-19

Axial3D Insight

K250369

Axial Medical Printing Limited

QIH · Radiology · 2025-09-18

ECHELON Synergy

K251386

Fujifilm Corporation

LNH · Radiology · 2025-09-17

Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)

K251221

Abbott

MXD · Cardiovascular · 2025-09-17

InferOperate Suite

K250237

Beijing Infervision Healthcare Medical Technology Co., Ltd.

QIH · Radiology · 2025-09-15

Stethophone Pro

K252595

Sparrow Acoustics, Inc.

DQD · Cardiovascular · 2025-09-12

CADDIE

K252586

Odin Medical Limited

QNP · Gastroenterology-Urology · 2025-09-12

Volta AF-Xplorer II

K251518

Volta Medical

DQK · Cardiovascular · 2025-09-12

FETOLY

K251368

Diagnoly

IYN · Radiology · 2025-09-12

SIGNA Sprint

K251399

GE Medical Systems, LLC

LNH · Radiology · 2025-09-11

Mazor X System / Mazor X Stealth Edition

K251316

Mazor Robotics Ltd.

OLO · Neurology · 2025-09-11

Hypertension Notification Feature (HTNF)

K250507

Apple Inc.

SFR · Cardiovascular · 2025-09-11

AngioWaveNet

K244002

Angiowave Imaging, Inc.

QIH · Radiology · 2025-09-10

Corvair Monza

LOGIQ Totus

LOGIQ Fortis

DS Core Detect

BriefCase-Triage: CARE Multi-triage CT Body

HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System

TruSPECT Processing Station

ART-Plan+ (v3.1.0)

AIR Recon DL

SKOUT system

PeekMed web

Lumify Diagnostic Ultrasound System

BioticsAI

MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.Rise

Alzevita

eMurmur Heart AI

AI-CVD

Assert-IQ (DM5100)

PVAD IQ Software

MediAI-BA

Neosoma Brain Mets

UltraSight Guidance

prolaio eVO2peak Module (Version 1.0)

IRISeg

Swoop® Portable MR Imaging® System

DeepRhythmAI

CogNet AI-MT+

SANSA HSAT

INFINITT DPS

Fetal EchoScan (v1.2)

Ceribell Delirium Monitor System

Gastric Alimetry

Personalized Therapy Comfort Settings (PTCS)

Overjet CBCT Assist

ARTAssistant

AVIEW Lung Nodule CAD

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

Cartesion Prime (PCD-1000A/3) V10.21

CT VScore+

OEC One CFD

7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)

Scaida BrainCT-ICH (v1.0)

a2z-Unified-Triage

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

Nelli (Version 7.11)

CardioVision

MAGNETOM Free.Max; MAGNETOM Free.Star

DeepRESP

DTX Studio Assist

AutoDensity

Second Opinion® Panoramic

PeekMed web

Fibresolve (with PCCP)

SugarBug (1.x)

BriefCase-Triage

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

3mensio Workstation

Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System

AiORTA - Plan

LOGIQ E10

LOGIQ E10s

SANSA HSAT

cvi42 Coronary Plaque Software Application

Syngo Carbon Clinicals (VA41)

TeraRecon Cardiovascular.Calcification.CT

ANDI 2.0

brAIn Shoulder Positioning

X9 Ultrasound System

X1-FFR

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging

HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

AIAS Cephalon

BlineSlide

MAGENTIQ-COLO (ME-APDS)

xvision Spine system

Bunkerhill MAC

LungQ 4

SpineAR SNAP (SyncAR Spine)

SMART PCFD

brAIn Shoulder Positioning

SIGNA Sprint