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

RevealAI-Lung

🇺🇸Precision Medical Ventures, Inc. Dba Revealdx

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Multi-modalityWorkflow & image management510(k) 2026
US

uCT 780 with uWS-CT-Dual Energy Analysis

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2026
US

qXR-Detect

🇮🇳Qure.Ai Technologies

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2026
US

Diagnocat

🇺🇸DGNCT, LLC

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2026
US

BIOGRAPH One

🇩🇪Siemens Healthineers AG

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Multi-modalityWorkflow & image management510(k) 2026
US

EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)

🇸🇪Elekta Solutions AB

Accelerator, Linear, Medical

Multi-modalityWorkflow & image management510(k) 2026
US

VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)

🇮🇱Spectrum Dynamics Medical, Ltd.

System, Tomography, Computed, Emission

Multi-modalityWorkflow & image management510(k) 2026
US

LOGIQ Totus

🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2026
US

DS Core Detect

🇺🇸Dentsply Sirona, Inc.

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2026
US

LOGIQ Fortis

🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2026
US

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

🇰🇷Samsung Medison Co., Ltd.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2026
US

AIR Recon DL

🇺🇸Ge Medical Systems, LLC

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
US

ART-Plan+ (v3.1.0)

Therapanacea Sas

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2025
US

BioticsAI

Bioticsai, Inc.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

Lumify Diagnostic Ultrasound System

🇺🇸Philips Ultrasound, LLC

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

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

🇩🇪Siemens Healthcare GmbH

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
US

UltraSight Guidance

Ultrasight , Ltd.

Image Acquisition And/Or Optimization Guided By Artificial Intelligence

Multi-modalityWorkflow & image management510(k) 2025
US

Swoop® Portable MR Imaging® System

🇺🇸Hyperfine, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
US

Fetal EchoScan (v1.2)

🇫🇷Brightheart

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Multi-modalityWorkflow & image management510(k) 2025
US

AVIEW Lung Nodule CAD

🇰🇷Coreline Soft Co.,Ltd

Lung Computed Tomography System, Computer-Aided Detection

Multi-modalityWorkflow & image management510(k) 2025
US

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

🇯🇵Canon Medical Systems Corporation

System, Tomography, Computed, Emission

Multi-modalityWorkflow & image management510(k) 2025
US

CT VScore+

🇺🇸Canon Medical Informatics, Inc.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2025
US

OEC One CFD

Ge Hualun Medical Systems Co. , Ltd.

Image-Intensified Fluoroscopic X-Ray System, Mobile

Multi-modalityWorkflow & image management510(k) 2025
US

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

🇮🇹Esaote, S.p.A.

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

Voluson Expert 18; Voluson Expert 20; Voluson Expert 22

🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2025
US

Senographe Pristina 3D

🇺🇸GE Healthcare

Digital Breast Tomosynthesis

Multi-modalityWorkflow & image managementPMA 2025
US

MAGNETOM Free.Max; MAGNETOM Free.Star

🇨🇳Siemens Shenzhen Magnetic Resonance , Ltd.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2025
US

DTX Studio Assist

🇧🇪Nobel Biocare C/O Medicim NV

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2025
US

Second Opinion® Panoramic

🇺🇸Pearl, Inc.

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2025
US

SugarBug (1.x)

🇺🇸Bench7, Inc.

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2025
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