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

Fibresolve (with PCCP)

Imvaria, Inc.

Radiology Software For Referral Of Findings Related To Fibrotic Lung Disease.

Multi-modalityWorkflow & image management510(k) 2025
US

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

🇺🇸Mighty Oak Medical

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2025
US

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

🇯🇵Canon Medical Systems Corporation

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

LOGIQ E10

🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

LOGIQ E10s

🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

X9 Ultrasound System

🇺🇸X9, Inc.

Ultrasound Imaging For Vascular Access For Hemodialysis

Multi-modalityWorkflow & image management510(k) 2025
US

X1-FFR

🇺🇸Spectrawave, Inc.

X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device

Multi-modalityWorkflow & image management510(k) 2025
US

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

🇯🇵Canon Medical Systems Corporation

Interventional Fluoroscopic X-Ray System

Multi-modalityWorkflow & image management510(k) 2025
US

EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

🇺🇸Philips Ultrasound, LLC

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

Bunkerhill MAC

🇺🇸BunkerHill Health

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2025
US

LungQ 4

🇳🇱Thirona BV

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2025
US

uMR 680

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
US

uDR Aurora CX

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, X-Ray, Stationary

Multi-modalityWorkflow & image management510(k) 2025
US

Videa Dental AI

🇺🇸VideaHealth Inc.

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2025
US

ECHELON Synergy

🇯🇵Fujifilm Corporation

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
US

FETOLY

🇫🇷Diagnoly

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

SIGNA™ Sprint

🇺🇸Ge Medical Systems, LLC

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
US

MuscleView 2.0

Springbok, Inc. (dba Springbok Analytics)

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
US

BioTraceIO Vision (V1.7)

Techsomed Medical Technologies

Radiological Image Processing Software For Ablation Therapy Planning And Evaluation

Multi-modalityWorkflow & image management510(k) 2025
US

Dose+ (1.0)

🇫🇮Mvision AI Oy

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2025
US

OsteoSight™ Hip (v1)

🇬🇧Naitive Technologies Ltd

Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

Multi-modalityWorkflow & image management510(k) 2025
US

VELMENI for DENTISTS (V4D)

Velmeni Inc.

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2025
US

Sonosite LX and Sonosite PX Ultrasound Systems

🇺🇸Fujifilm Sonosite Inc

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

SurgiTwin

Twinsight

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2025
US

Definium Tempo Select

Ge Hualun Medical Systems Co. , Ltd.

System, X-Ray, Stationary

Multi-modalityWorkflow & image management510(k) 2025
US

Vista OS, Vista AI Scan, RTHawk

🇺🇸Vista AI, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
US

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

🇺🇸Siemens Medical Solutions USA, Inc.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

uMR Jupiter

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
US

Revolution Vibe

🇺🇸Ge Medical Systems, LLC

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2025
US

YSIO X.pree

🇩🇪Siemens Medical Solutions

System, X-Ray, Stationary

Multi-modalityWorkflow & image management510(k) 2025
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