AI Devices

Workflow & image management

Radiology AI devices in the Workflow & image management category, FDA-cleared or EU CE-marked, newest clearance first. Information only, never clinical advice.

US

Spectral CT Verida Family

🇮🇱Philips Medical Systems Technologies , Ltd.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2026
US

Butterfly Gestational Age Tool

🇺🇸Butterfly Network, Inc.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2026
US

Automated Aortic Stenosis Software (AutoAS)

🇺🇸GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Multi-modalityWorkflow & image management510(k) 2026
US

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

🇺🇸Philips Ultrasound, LLC

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2026
US

Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR

🇯🇵Canon Medical Systems Corporation

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2026
US

S-scan Open (100001800)

🇮🇹Esaote, S.p.A.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2026
US

Trinias

🇯🇵Shimadzu Corporation

Interventional Fluoroscopic X-Ray System

Multi-modalityWorkflow & image management510(k) 2026
US

LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power

🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2026
US

CT Rembra RT; CT Areta RT; CT Rembra

🇨🇳Philips Healthcare (Suzhou) Co., Ltd.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2026
US

True Definition DL

🇯🇵Ge Healthcare Japan Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2026
US

Photonova Spectra, Photonova Spectra Select

🇺🇸Ge Medical Systems, LLC

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2026
US

SOMATOM X.cite; SOMATOM X.ceed

🇺🇸Siemens Medical Solutions USA, Inc.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2026
US

syngo.via RT Image Suite VC10

🇺🇸Varian Medical Systems, Inc.

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2026
US

Sonio Detect (v3)

🇨🇫Sonio

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2026
US

Aquilion ServeSP (TSX-307B) V2.0

🇯🇵Canon Medical Systems Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2026
US

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)

🇯🇵Canon Medical Systems Corporation

Interventional Fluoroscopic X-Ray System

Multi-modalityWorkflow & image management510(k) 2026
US

LiverMultiScan (v6.0)

🇬🇧Perspectum, Ltd.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2026
US

Bunkerhill Contrast CAC

🇺🇸BunkerHill Health

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2026
US

Bunkerhill Contrast AVC

🇺🇸BunkerHill Health

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2026
US

AV Cardiac CT

🇳🇱Philips Medical Systems Nederland B.V.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2026
US

Magnifico Open (100009900)

🇮🇹Esaote, S.p.A.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2026
US

QT Scanner 2000 Model A

QT Imaging Holdings, Inc.

System, Imaging, Pulsed Echo, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2026
US

Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades

🇳🇱Philips Medical Systems Nederland B.V.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2026
US

MAGNETOM Flow.Ace; MAGNETOM Flow.Plus

🇨🇳Siemens Shenzhen Magnetic Resonance , Ltd.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2026
US

CARA System

Cara Medical, Ltd.

Interventional Fluoroscopic X-Ray System

Multi-modalityWorkflow & image management510(k) 2026
US

Monaco RTP System (6.3)

🇸🇪Elekta Solutions AB

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2026
US

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, Tomography, Computed, Emission

Multi-modalityWorkflow & image management510(k) 2026
US

Delivery Date AI

🇺🇸Ultrasound AI

Radiological Software System For Delivery Date Prediction

Multi-modalityWorkflow & image managementDe Novo 2026
US

SIGNA™ Bolt

🇺🇸Ge Medical Systems, LLC

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2026
US

SIGNA™ Sprint Select

🇺🇸Ge Medical Systems, LLC

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2026
Page 1 of 20Older