FDA-cleared — AI devices
Radiology AI devices on the FDA's AI-Enabled Device List (the Radiology panel). The list is not comprehensive and lags publication of decision summaries. Information only, never clinical advice.
See-Mode Augmented Reporting Tool, Thyroid (SMART-T)
See-Mode Technologies Pte. Ltd.
Breast CAD (tomosynthesis)
uAI Portal
Shanghai United Imaging Intelligence Co., Ltd.
MR image reconstruction/enhancement
TRAQinform IQ
AIQ Global, Inc.
System, Image Processing, Radiological
Velacur
🇨🇦Sonic Incytes
System, Imaging, Pulsed Echo, Ultrasonic
Velmeni for Dentists (V4D)
Velmeni Inc.
Analyzer, Medical Image
Imbio PHA (4.0.0)
Imbio, Inc.
MR image reconstruction/enhancement
uMI Panorama
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Tomography, Computed, Emission
MI View&GO
🇺🇸Siemens Medical Solutions USA, Inc.
MR image reconstruction/enhancement
syngo.via MI Workflows; Scenium; syngo MBF
🇺🇸Siemens Medical Solutions USA, Inc.
MR image reconstruction/enhancement
Kosmos
🇺🇸EchoNous, Inc.
System, Imaging, Pulsed Doppler, Ultrasonic
Overjet Charting Assist
Overjet, Inc.
MR image reconstruction/enhancement
NeuroQuant
🇺🇸CorTechs Labs, Inc.
MR image reconstruction/enhancement
AiMIFY (1.x)
🇺🇸Subtle Medical, Inc.
System, Image Processing, Radiological
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR
🇯🇵Canon Medical Systems Corporation
System, Nuclear Magnetic Resonance Imaging
HealthCCSng
🇮🇱Nano-X AI Ltd.
System, X-Ray, Tomography, Computed
qCT LN Quant
🇮🇳Qure.Ai Technologies
MR image reconstruction/enhancement
uMI Panvivo
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Tomography, Computed, Emission
CoLumbo
🇧🇬Smart Soft Healthcare
MR image reconstruction/enhancement
ECHELON Synergy MRI System
🇯🇵FUJIFILM Healthcare Corporation
System, Nuclear Magnetic Resonance Imaging
OptimMRI (v2)
Rebrain, SAS
MR image reconstruction/enhancement
i2Contour
MRIMath LLC
MR image reconstruction/enhancement
Omni Legend
🇮🇱GE Medical Systems Israel, Functional Imaging
System, Tomography, Computed, Emission
AI Platform 2.0 (AIP002)
🇺🇸Exo Imaging
MR image reconstruction/enhancement
AISAP Cardio V1.0
🇮🇱Aisap
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
CardIQ Suite
🇫🇷GE Medical Systems SCS
System, X-Ray, Tomography, Computed
MammoScreen® (3)
🇺🇸Therapixel
Breast CAD (tomosynthesis)
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
Rayvolve
🇫🇷AZmed SAS
Radiological Computer Assisted Detection/Diagnosis Software For Fracture
MICSI-RMT
🇺🇸Microstructure Imaging, Inc.
System, Image Processing, Radiological
Swoop® Portable MR Imaging® System
🇺🇸Hyperfine, Inc.
System, Nuclear Magnetic Resonance Imaging
