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.

BriefCase

K192383

Aidoc Medical, Ltd.

QAS · Radiology · 2019-12-20

QLAB Advanced Quantification Software

K191647

Philips Healthcare

QIH · Radiology · 2019-12-20

syngo.CT CaScoring

K192763

Siemens Medical Solutions USA, Inc.

JAK · Radiology · 2019-12-17

Deep Learning Image Reconstruction

K193170

GE Healthcare Japan Corporation

JAK · Radiology · 2019-12-13

QyScore Software

K192531

Qynapse

LLZ · Radiology · 2019-12-13

Icobrain

K192130

Icometrix NV

LLZ · Radiology · 2019-12-13

NemoScan

K192571

Software Nemotec S.L.

LLZ · Radiology · 2019-12-11

Transpara

K192287

Screenpoint Medical B.V.

QDQ · Radiology · 2019-12-10

FFRangio

K192442

CathWorks Ltd

QEK · Cardiovascular · 2019-12-09

PhantomMSK Trauma

K192279

OrthoGrid Systems Inc.

LLZ · Radiology · 2019-12-07

7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application

K192945

7D Surgical Inc.

HAW · Neurology · 2019-11-27

HealthCXR

K192320

Zebra Medical Vision, Ltd.

QFM · Radiology · 2019-11-26

SOZO

K190529

ImpediMed Limited

QJB · Cardiovascular · 2019-11-25

RSI-MRI+

K191278

MultiModal Imaging Services Corporation (dba HealthLytix)

LLZ · Radiology · 2019-11-19

EchoGo Core

K191171

Ultromics Ltd

QIH · Radiology · 2019-11-13

MEDIP PRO

K191026

MEDICALIP Co., Ltd

LLZ · Radiology · 2019-11-07

KOALA

K192109

IB Lab GmbH

LLZ · Radiology · 2019-11-05

Cleerly Labs

K190868

Cleerly Inc

LLZ · Radiology · 2019-11-05

WellDoc BlueStar

K190013

WellDoc, Inc.

MRZ · General Hospital · 2019-11-04

Sight OLO

K190898

Sight Diagnostics Ltd.

GKZ · Hematology · 2019-11-01

MIMOSA Imager

K190334

MIMOSA Diagnostics Inc

MUD · Cardiovascular · 2019-11-01

RTHawk, HeartVista Cardiac Package

K183274

HeartVista, Inc.

LNH · Radiology · 2019-10-18

Merge PACS

K192455

Merge Healthcare Incorporated

LLZ · Radiology · 2019-10-17

Ventripoint Medical System Plus (VMS+) 3.0

K191493

Ventripoint Diagnostics, Ltd.

LLZ · Radiology · 2019-10-16

ProFound AI Software V2.1

K191994

iCAD Inc.

QDQ · Radiology · 2019-10-04

CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)

K191713

Omega Medical Imaging, LLC

JAA · Radiology · 2019-10-04

Syngo.Via RT Image Suite

K192065

Siemens Medical Solutions USA, Inc.

MUJ · Radiology · 2019-09-18

SubtleMR

K191688

Subtle Medical, Inc.

LLZ · Radiology · 2019-09-16

SIS Software Version 3.6.0

K192304

Surgical Information Sciences, Inc.

LLZ · Radiology · 2019-09-13

BrainScope TBI

K190815

BrainScope Company, Inc.

PIW · Neurology · 2019-09-11

PeraMobile and PeraWatch

K183370

PeraHealth, Inc.

MWI · Cardiovascular · 2019-09-11

AI-Rad Companion (Cardiovascular)

K183268

Siemens Medical Solutions USA, Inc.

JAK · Radiology · 2019-09-10

Myo Plus

K191179

Otto Bock Healthcare Products GmbH

GXY · Neurology · 2019-09-04

Clarius Ultrasound Scanner

K192107

Clarius Mobile Health Corp.

IYN · Radiology · 2019-08-29

D2P

K183489

3D Systems, Inc.

LLZ · Radiology · 2019-08-29

Zio XT ECG Monitoring System, Zio AT ECG Monitoring System

K190593

iRhythm Technologies, Inc.

DQK · Cardiovascular · 2019-08-23

HeartFlow FFRct Analysis

K190925

HeartFlow, Inc.

PJA · Cardiovascular · 2019-08-15

Biovitals Analytics Engine

K183282

Biofourmis Singapore Pte. Ltd

PLB · Cardiovascular · 2019-08-15

Critical Care Suite

K183182

GE Medical Systems, LLC.

QFM · Radiology · 2019-08-12

aBSI

K191262

EXINI Diagnostics AB

LLZ · Radiology · 2019-08-05

EyeBOX

K191183

Oculogica, Inc.

QEA · Neurology · 2019-07-31

AI-Rad Companion (Pulmonary)

K183271

Siemens Medical Solutions USA, Inc.

JAK · Radiology · 2019-07-26

ACR LAB Urine Analysis Test System

K182384

Healthy.io Ltd

JFY · Clinical Chemistry · 2019-07-26

KIDScore D3

K182798

Vitrolife A/S

PBH · Obstetrics and Gynecology · 2019-07-19

DreaMed Advisor Pro

K191370

DreaMed Diabetes Ltd

QCC · Clinical Chemistry · 2019-07-18

iNtuition-Structural Heart Module

K191585

TeraRecon Inc.

LLZ · Radiology · 2019-07-12

physIQ Heart Rhythm and Respiratory Module

K183322

physIQ, Inc

DPS · Cardiovascular · 2019-07-10

DeepCT

K182875

Deep01 Limited

QAS · Radiology · 2019-07-10

RayCare 2.3

K191384

RaySearch Laboratories AB (publ)

MUJ · Radiology · 2019-07-08

Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE

K182901

Canon Medical Systems Corporation

JAK · Radiology · 2019-07-05

Koios DS for Breast

K190442

Koios Medical, Inc.

POK · Radiology · 2019-07-03

LiverMultiScan (LMSv3)

K190017

Perspectum Diagnostics Ltd

LNH · Radiology · 2019-06-27

CLARUS

K191194

Carl Zeiss Meditec, Inc

QER · Ophthalmic · 2019-06-25

RayStation

K190387

RaySearch Laboratories AB (publ)

MUJ · Radiology · 2019-06-19

HealthICH

K190424

Zebra Medical Vision Ltd.

QAS · Radiology · 2019-06-13

ClariCT.AI

K183460

ClariPI Inc.

LLZ · Radiology · 2019-06-13

Aquilion ONE (TSX-305A/6) V8.9 with AiCE

K183046

Canon Medical Systems Corporation

JAK · Radiology · 2019-06-12

BriefCase

K190896

Aidoc Medical, Ltd.

QAS · Radiology · 2019-05-31

COMPLETE CONTROL System Gen2

K191083

Coapt, LLC

GXY · Neurology · 2019-05-24

Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure

K183646

Edwards Lifeciences, LLC

QAQ · Cardiovascular · 2019-05-21

APAS Independence with Urine Analysis Module

K183648

Clever Culture Systems AG

PPU · Microbiology · 2019-05-15

SurgicalAR

K190764

MEDIVIS, Inc.

LLZ · Radiology · 2019-05-13

HealthPNX

K190362

Zebra Medical Vision Ltd.

QFM · Radiology · 2019-05-06

FluChip-8G Influenza A+B Assay

K182513

InDevR, Inc.

OZE · Microbiology · 2019-04-22

Lung Vision System

K183593

Body Vision Medical Ltd.

LLZ · Radiology · 2019-04-18

eMurmur ID

K181988

CSD Labs GmbH

DQD · Cardiovascular · 2019-04-17

BriefCase

K190072

Aidoc Medical, Ltd.

QAS · Radiology · 2019-04-15

Deep Learning Image Reconstruction

K183202

GE Medical Systems, LLC.

JAK · Radiology · 2019-04-12

Bone VCAR (BVCAR)

K183204

GE Medical Systems SCS

JAK · Radiology · 2019-04-08

Loop System

K181352

Spry Health, Inc.

DQA · Cardiovascular · 2019-03-29

SIS Software version 3.3.0

K183019

Surgical Information Sciences, Inc.

LLZ · Radiology · 2019-03-19

KardiaAI

K181823

AliveCor, Inc.

DQK · Cardiovascular · 2019-03-11

cmTriage

K183285

CureMetrix, Inc

QFM · Radiology · 2019-03-08

RhythmAnalytics

K182344

Biofourmis Singapore Pte. Ltd.

DQK · Cardiovascular · 2019-03-07

RX-1 Rhythm Express Remote Cardiac Monitoring System

K183704

VivaQuant Inc.

DXH · Cardiovascular · 2019-02-16

d-Nav System

K181916

Hygieia, Inc

NDC · Anesthesiology · 2019-02-04

AI Rad Companion (Engine)

K183272

Siemens Medical Solutions USA, Inc.

LLZ · Radiology · 2019-02-01

SIGNA Premier

K183231

GE Medical Systems, LLC

LNH · Radiology · 2019-01-18

Study Watch

K182456

Verily Life Sciences LLC

DXH · Cardiovascular · 2019-01-17

MRCP+ v1.0

K183133

Perspectum Diagnostics Ltd

LLZ · Radiology · 2019-01-09

AmCAD-UO

K180867

AmCad BioMed Corporation

LLZ · Radiology · 2018-12-28

EyeBOX

DEN170091

Oculogica, Inc.

QEA · Neurology · 2018-12-28

Quantib ND

K182564

Quantib BV

LLZ · Radiology · 2018-12-27

iSchemaView RAPID

K182130

iSchemaView, Inc.

LLZ · Radiology · 2018-12-27

vascuCAP

K183012

Elucid Bioimaging Inc.

LLZ · Radiology · 2018-12-21

Embrace

K181861

Empatica Srl

POS · Neurology · 2018-12-20

FFRangio System

K182149

CathWorks Ltd

QEK · Cardiovascular · 2018-12-19

Cardio-TriTest v6.5

K182790

Cardio-Phoenix Inc.

DPS · Cardiovascular · 2018-12-14

Centricity Universal Viewer

K182419

GE Healthcare

LLZ · Radiology · 2018-12-14

PowerLook Tomo Detection V2 Software

K182373

iCAD Inc.

QDQ · Radiology · 2018-12-06

FFRct

K182035

HeartFlow, Inc

PJA · Cardiovascular · 2018-12-06

AMRA Profiler

K173749

AMRA Medical AB

LNH · Radiology · 2018-12-06

SubtlePET

K182336

Subtle Medical, Inc.

KPS · Radiology · 2018-11-30

FerriSmart Analysis System

K182218

Resonance Health Analysis Services Pty Ltd

PCS · Radiology · 2018-11-30

Persyst 14 EEG Review and Analysis Software

K182181

Persyst Development Corporation

OMB · Neurology · 2018-11-29

Transpara

K181704

ScreenPoint Medical BV

QDQ · Radiology · 2018-11-21

Vitrea CT Brain Perfusion

K181247

Vital Images, Inc.

LLZ · Radiology · 2018-11-20

AI-ECG Platform

K180432

Shenzhen Carewell Electronics., Ltd

DQK · Cardiovascular · 2018-11-19

LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer

K180343

Bonraybio Co., Ltd.

POV · Hematology · 2018-11-16

icobrain

K181939

icometrix NV

LLZ · Radiology · 2018-11-06

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.