Cleared in 2024
Radiology AI devices with a 2024 FDA clearance date. The list lags publication of decision summaries, so recent counts keep rising. Information only, never clinical advice.
Constellation (CON-001)
Q Bio, Inc.
MR image reconstruction/enhancement
CINA-CSpine
🇫🇷Avicenna.AI
Triage & notification (CADt)
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700)
🇯🇵Canon Medical Systems Corporation
System, Imaging, Pulsed Doppler, Ultrasonic
FETOLY-HEART
🇫🇷Diagnoly
System, Imaging, Pulsed Doppler, Ultrasonic
LumiNE US; Lumi
Augmedit B.V.
MR image reconstruction/enhancement
ADAS 3D
🇪🇸Adas3D Medical S.L
MR image reconstruction/enhancement
Overjet Image Enhancement Assist
Overjet, Inc.
MR image reconstruction/enhancement
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
