AI Devices

Multi-modality AI devices

Radiology AI devices for Multi-modality imaging, FDA-cleared or EU CE-marked, newest clearance first. Information only, never clinical advice.

US

ART-Plan (v.2.2.0)

Therapanacea Sas

System, Planning, Radiation Therapy Treatment

Multi-modalityWorkflow & image management510(k) 2024
US

Rapid

iSchema View Inc.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2024
US

VisAble.IO

🇮🇱Techsomed

Radiological Image Processing Software For Ablation Therapy Planning And Evaluation

Multi-modalityWorkflow & image management510(k) 2024
US

Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR

🇯🇵Canon Medical Systems Corporation

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2024
US

True Enhance DL

🇯🇵Ge Healthcare Japan Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2024
US

uMR 680

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2024
US

Rho

🇨🇦16 Bit Inc

Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

Multi-modalityWorkflow & image managementDe Novo 2024
EmergencyUS

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

Ever Fortune.Ai, Co., Ltd.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2024
US

Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System

🇯🇵Canon Medical Systems Corporation

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2024
US

NAEOTOM Alpha

🇺🇸Siemens Medical Solutions USA, Inc.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2024
US

SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed

🇺🇸Siemens Medical Solutions USA, Inc.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2024
US

MAGNETOM Terra; MAGNETOM Terra.X

🇺🇸Siemens Medical Solutions USA, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2024
EmergencyUS

syngo.CT Brain Hemorrhage

🇺🇸Siemens Medical Solutions USA, Inc.

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2024
US

uMR Omega

🇨🇳Shanghai United Imaging Healthcare Co., Ltd.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2024
US

AI-Rad Companion (Pulmonary)

🇩🇪Siemens Healthcare GmbH

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2024
US

CINA-ASPECTS

🇫🇷Avicenna.AI

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Multi-modalityWorkflow & image management510(k) 2024
EmergencyUS

CINA-iPE

🇫🇷Avicenna.AI

Triage & notification (CADt)

Multi-modalityTriage & notification (CADt)510(k) 2024
US

Voluson Signature 20, Voluson Signature 18

🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
US

EdgeFlow UH10

🇰🇷Edgecare Inc.

System, Imaging, Pulsed Echo, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
US

Overjet Caries Assist-Pediatric

Overjet, Inc.

Analyzer, Medical Image

Multi-modalityWorkflow & image management510(k) 2024
US

MAGNETOM Cima.X Fit

🇺🇸Siemens Medical Solutions USA, Inc.

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2024
US

Revolution Ascend Sliding

🇨🇳GE Hangwei Medical Systems Co., Ltd.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2024
US

EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

🇺🇸Philips Ultrasound, LLC

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
US

HealthFLD

🇮🇱Nano-X AI Ltd.

System, X-Ray, Tomography, Computed

Multi-modalityWorkflow & image management510(k) 2024
US

CEPHX- Cephalometric Analysis Software

Orca Dental AI , Ltd.

System, Image Processing, Radiological

Multi-modalityWorkflow & image management510(k) 2024
US

Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System

🇯🇵Canon Medical Systems Corporation

System, Imaging, Pulsed Doppler, Ultrasonic

Multi-modalityWorkflow & image management510(k) 2024
US

SIGNA Champion

🇨🇳GE Healthcare (Tianjin) Company Limited

System, Nuclear Magnetic Resonance Imaging

Multi-modalityWorkflow & image management510(k) 2024
US

Rapid ASPECTS (v3)

🇺🇸iSchemaView, Inc.

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Multi-modalityWorkflow & image management510(k) 2024
US

Radify Triage

Envisionit DeepAI Ltd

Lesion detection/diagnosis software

Multi-modalityDetection (CADe)510(k) 2024
US

Biograph VK10

🇺🇸Siemens Medical Solutions USA, Inc.

System, Tomography, Computed, Emission

Multi-modalityWorkflow & image management510(k) 2024
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