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.

JBS-LVO

K241480

JLK, Inc.

QAS · Radiology · 2024-09-27

encevis (2.1)

K240993

AIT Austrian Institute of Technology GmbH

OMB · Neurology · 2024-09-27

CAC (gated) Algorithm

K240369

BunkerHill Health

JAK · Radiology · 2024-09-27

uAI Easy Triage ICH

K242292

Shanghai United Imaging Intelligence Co., Ltd.

QAS · Radiology · 2024-09-24

EchoGo Heart Failure (2.0)

K240013

Ultromics Limited

QUO · Cardiovascular · 2024-09-23

PIUR tUS Infinity

K240036

PIUR Imaging GmbH

QIH · Radiology · 2024-09-20

Sleep Apnea Notification Feature (SANF)

K240929

Apple Inc.

QZW · Anesthesiology · 2024-09-13

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)

K241582

Canon Medical Systems Corporation

IYN · Radiology · 2024-09-12

Constellation (CON-001)

K241280

Q Bio, Inc.

QIH · Radiology · 2024-09-12

CINA-CSpine

K240942

Avicenna.AI

QAS · Radiology · 2024-09-12

FETOLY-HEART

K241380

Diagnoly

IYN · Radiology · 2024-09-11

LumiNE US; Lumi

K240094

Augmedit B.V.

QIH · Radiology · 2024-09-10

Overjet Image Enhancement Assist

K241681

Overjet Inc

QIH · Radiology · 2024-09-09

ADAS 3D

K240791

Adas3D Medical S.L

QIH · Radiology · 2024-09-09

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

K240697

See-Mode Technologies Pte. Ltd.

QDQ · Radiology · 2024-09-09

uAI Portal

K240411

Shanghai United Imaging Intelligence Co., Ltd.

QIH · Radiology · 2024-09-06

TRAQinform IQ

K233998

AIQ Global, Inc.

LLZ · Radiology · 2024-09-05

Velacur

K233977

Sonic Incytes

IYO · Radiology · 2024-09-04

MI View&GO

K242300

Siemens Medical Solutions USA, Inc.

QIH · Radiology · 2024-08-30

syngo.via MI Workflows; Scenium; syngo MBF

K242275

Siemens Medical Solutions USA, Inc.

QIH · Radiology · 2024-08-30

Imbio PHA (4.0.0)

K241847

Imbio, Inc

QIH · Radiology · 2024-08-30

uMI Panorama

K241585

Shanghai United Imaging Healthcare Co.,Ltd.

KPS · Radiology · 2024-08-30

Velmeni for Dentists (V4D)

K240003

Velmeni Inc.

MYN · Radiology · 2024-08-30

Kosmos

K233826

EchoNous, Inc.

IYN · Radiology · 2024-08-29

Overjet Charting Assist

K241684

Overjet, Inc

QIH · Radiology · 2024-08-27

NeuroQuant

K241098

CorTechs Labs, Inc.

QIH · Radiology · 2024-08-22

AiMIFY (1.x)

K240290

Subtle Medical, Inc.

LLZ · Radiology · 2024-08-21

Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR

K241496

Canon Medical Systems Corporation

LNH · Radiology · 2024-08-20

HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece

K240200

Procept BioRobotics

PZP · General and Plastic Surgery · 2024-08-20

HealthCCSng

K241440

Nano-X AI Ltd.

JAK · Radiology · 2024-08-19

qCT LN Quant

K240740

Qure.ai Technologies

QIH · Radiology · 2024-08-16

HeartKey® Rhythm

K233755

B-Secur Limited

DQK · Cardiovascular · 2024-08-16

uMI Panvivo

K241596

Shanghai United Imaging Healthcare Co., Ltd.

KPS · Radiology · 2024-08-15

CoLumbo

K241211

Smart Soft Healthcare

QIH · Radiology · 2024-08-15

ECHELON Synergy MRI System

K241429

FUJIFILM Healthcare Corporation

LNH · Radiology · 2024-08-13

OptimMRI (v2)

K242054

Rebrain, SAS

QIH · Radiology · 2024-08-12

Omni Legend

K241665

GE Medical Systems Israel, Functional Imaging

KPS · Radiology · 2024-08-08

i2Contour

K233822

MRIMath LLC

QIH · Radiology · 2024-08-08

AI Platform 2.0 (AIP002)

K240953

Exo Imaging

QIH · Radiology · 2024-08-05

Precision AI Surgical Planning System (PAI-SPS)

K233992

Precision AI Pty Ltd

QHE · Orthopedic · 2024-08-05

Acumen Assisted Fluid Management (AFM) Software Feature

K233984

Edwards Lifesciences, LLC

QMS · Cardiovascular · 2024-08-02

MammoScreen® (3)

K240301

Therapixel

QDQ · Radiology · 2024-08-01

AISAP Cardio V1.0

K234141

Aisap

POK · Radiology · 2024-08-01

CardIQ Suite

K233731

GE Medical Systems SCS

JAK · Radiology · 2024-08-01

GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US)

K241887

Cosmo Artificial Intelligence - AI Ltd

QNP · Gastroenterology-Urology · 2024-07-25

CADDIE

K240044

Odin Medical Limited

QNP · Gastroenterology-Urology · 2024-07-24

ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System

K240704

Siemens Medical Solutions, USA, Inc.

IYN · Radiology · 2024-07-22

MICSI-RMT

K241121

Microstructure Imaging, Inc.

LLZ · Radiology · 2024-07-17

Rayvolve

K240845

AZmed SAS

QBS · Radiology · 2024-07-17

Swoop® Portable MR Imaging® System

K240944

Hyperfine, Inc.

LNH · Radiology · 2024-07-16

Huxley SANSA Home Sleep Apnea Test (1000-00)

K240285

Huxley Medical

MNR · Anesthesiology · 2024-07-15

BriefCase-Triage

K241727

Aidoc Medical, Ltd.

QAS · Radiology · 2024-07-12

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

K234009

Mighty Oak Medical

QIH · Radiology · 2024-07-12

RUS

K233457

Hutom Inc.

QIH · Radiology · 2024-07-12

SubtleSYNTH (1.x)

K241329

Subtle Medical, Inc.

QIH · Radiology · 2024-07-11

SKOUT® system

K241508

Iterative Scopes, Inc.

QNP · Gastroenterology-Urology · 2024-07-03

SMART Bun-Yo-Matic X-Ray

K240736

Disior Ltd

QIH · Radiology · 2024-07-02

Tyto Insights for Crackles Detection

K240555

Tyto Care Ltd.

PHZ · Anesthesiology · 2024-07-02

Hyper Insight - ICH

K240353

SK Inc.

QAS · Radiology · 2024-07-01

VEA Align; spineEOS

K240582

EOS imaging

QIH · Radiology · 2024-06-25

V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System

K240631

Samsung Medison Co., Ltd.

IYN · Radiology · 2024-06-21

O-arm O2 Imaging System

K240465

Medtronic Navigation, Inc

OWB · Radiology · 2024-06-21

Tempus ECG-AF

K233549

Tempus AI, Inc.

SBQ · Cardiovascular · 2024-06-21

eCARTv5 Clinical Deterioration Suite (eCART)

K233253

AgileMD, Inc.

QNL · Cardiovascular · 2024-06-21

Medihub Prostate

K233196

JLK Inc.

QIH · Radiology · 2024-06-21

SMART Bun-Yo-Matic CT

K240642

Disior Ltd

QIH · Radiology · 2024-06-20

SIS System

K241083

Surgical Information Sciences, Inc.

QIH · Radiology · 2024-06-14

Clarius OB AI

K233955

Clarius Mobile Health Corp.

IYN · Radiology · 2024-06-14

Relu Creator

K233925

Relu BV

QIH · Radiology · 2024-06-13

Radiography 7300 C

K233662

Philips Medical Systems DMC GmbH

KPR · Radiology · 2024-06-13

RS85 Diagnostic Ultrasound System

K240516

Samsung Medison Co., Ltd.

IYN · Radiology · 2024-06-12

Cardiac CT Function Software Application

K241038

Circle Cardiovascular Imaging

QIH · Radiology · 2024-06-07

EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)

K234042

Ever Fortune.AI Co., Ltd.

QIH · Radiology · 2024-06-07

Impala

K232035

AliveCor, Inc.

DPS · Cardiovascular · 2024-06-07

Corvair

K231010

AliveCor, Inc.

MHX · Cardiovascular · 2024-06-07

CINA-VCF

K240612

Avicenna.AI

QFM · Radiology · 2024-05-31

LVivo IQS

K240769

DiA Imaging Analysis Ltd.

QIH · Radiology · 2024-05-24

uPMR 790

K234154

Shanghai United Imaging Healthcare Co., Ltd.

OUO · Radiology · 2024-05-24

Syngo Carbon Enterprise Access (VA40A)

K240294

Siemens Healthcare GmbH

LLZ · Radiology · 2024-05-23

VinDr-Mammo

K233108

VinBigData Joint Stock Company

QFM · Radiology · 2024-05-23

YSIO X.pree

K233543

Siemens Medical Solutions

KPR · Radiology · 2024-05-21

uOmnispace.CT

K233209

Shanghai United Imaging Healthcare Co., Ltd.

QIH · Radiology · 2024-05-17

DentalMonitoring

DEN230035

Dental Monitoring SAS

SBC · Dental · 2024-05-17

RAYDENT SW

K233625

RAY Co., Ltd.

PNN · Dental · 2024-05-16

BriefCase-Quantification

K241112

Aidoc Medical, Ltd.

QIH · Radiology · 2024-05-15

Heuron ICH

K233247

Heuron Co., Ltd.

QAS · Radiology · 2024-05-15

Notal Vision Home Optical Coherence Tomography (OCT) System

DEN230043

Notal Vision Inc

SAX · Ophthalmic · 2024-05-15

SmartChest

K232410

Milvue

QFM · Radiology · 2024-05-10

ASSURE Wearable ECG

K233864

Kestra Medical Technologies, Inc.

MWJ · Cardiovascular · 2024-05-07

DeepContour (V1.0)

K232928

Wisdom Technologies., Inc.

QKB · Radiology · 2024-05-07

ECHELON Synergy V10.0

K233687

Fujifilm Healthcare Americas Corporation

LNH · Radiology · 2024-05-03

CT 5300

K232491

Philips Healthcare (Suzhou) Co., Ltd.

JAK · Radiology · 2024-05-03

AUTION EYE AI-4510 Urine Particle Analysis System

K232416

Arkray Inc.

LKM · Hematology · 2024-05-03

Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)

K232923

Varian Medical Systems Inc.

IYE · Radiology · 2024-04-30

ARVIS® Shoulder

K240062

Insight Medical Systems, Inc.

OLO · Neurology · 2024-04-29

Sonio Detect

K240406

Sonio

IYN · Radiology · 2024-04-26

uMR Jupiter

K233673

Shanghai United Imaging Healthcare Co., Ltd

LNH · Radiology · 2024-04-26

syngo.via RT Image Suite

K232799

Siemens Medical Solutions USA, Inc.

MUJ · Radiology · 2024-04-26

InVision Precision LVEF (LVEF)

K232331

InVision Medical Technology Corporation

QIH · Radiology · 2024-04-25

EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

K240850

Philips Ultrasound LLC

IYN · Radiology · 2024-04-24

JBS-LVO

encevis (2.1)

CAC (gated) Algorithm

uAI Easy Triage ICH

EchoGo Heart Failure (2.0)

PIUR tUS Infinity

Sleep Apnea Notification Feature (SANF)

Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)

Constellation (CON-001)

CINA-CSpine

FETOLY-HEART

LumiNE US; Lumi

Overjet Image Enhancement Assist

ADAS 3D

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

uAI Portal

TRAQinform IQ

Velacur

MI View&GO

syngo.via MI Workflows; Scenium; syngo MBF

Imbio PHA (4.0.0)

uMI Panorama

Velmeni for Dentists (V4D)

Kosmos

Overjet Charting Assist

NeuroQuant

AiMIFY (1.x)

Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR

HYDROS Robotic System; HYDROS TRUS Probe; HYDROS Handpiece

HealthCCSng

qCT LN Quant

HeartKey® Rhythm

uMI Panvivo

CoLumbo

ECHELON Synergy MRI System

OptimMRI (v2)

Omni Legend

i2Contour

AI Platform 2.0 (AIP002)

Precision AI Surgical Planning System (PAI-SPS)

Acumen Assisted Fluid Management (AFM) Software Feature

MammoScreen® (3)

AISAP Cardio V1.0

CardIQ Suite

GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US)

CADDIE

ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System

MICSI-RMT

Rayvolve

Swoop® Portable MR Imaging® System

Huxley SANSA Home Sleep Apnea Test (1000-00)

BriefCase-Triage

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

RUS

SubtleSYNTH (1.x)

SKOUT® system

SMART Bun-Yo-Matic X-Ray

Tyto Insights for Crackles Detection

Hyper Insight - ICH

VEA Align; spineEOS

V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System

O-arm O2 Imaging System

Tempus ECG-AF

eCARTv5 Clinical Deterioration Suite (eCART)

Medihub Prostate

SMART Bun-Yo-Matic CT

SIS System

Clarius OB AI

Relu Creator

Radiography 7300 C

RS85 Diagnostic Ultrasound System

Cardiac CT Function Software Application

EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)

Impala

Corvair

CINA-VCF

LVivo IQS

uPMR 790

Syngo Carbon Enterprise Access (VA40A)

VinDr-Mammo

GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US)

eCARTv5 Clinical Deterioration Suite (eCART)