Cleared in 2025
Radiology AI devices with a 2025 FDA clearance date. The list lags publication of decision summaries, so recent counts keep rising. Information only, never clinical advice.
TruSPECT Processing Station
🇮🇱Spectrum Dynamics Medical, Ltd.
MR image reconstruction/enhancement
AIR Recon DL
🇺🇸Ge Medical Systems, LLC
System, Nuclear Magnetic Resonance Imaging
ART-Plan+ (v3.1.0)
Therapanacea Sas
System, Planning, Radiation Therapy Treatment
PeekMed web
🇵🇹Peek Health, S.A.
MR image reconstruction/enhancement
BioticsAI
Bioticsai, Inc.
System, Imaging, Pulsed Doppler, Ultrasonic
Lumify Diagnostic Ultrasound System
🇺🇸Philips Ultrasound, LLC
System, Imaging, Pulsed Doppler, Ultrasonic
Alzevita
🇬🇧TOPIA MEDTECH LIMITED
MR image reconstruction/enhancement
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
AI-CVD
🇺🇸HeartLung Corporation
MR image reconstruction/enhancement
MediAI-BA
Crescom Co., Ltd.
MR image reconstruction/enhancement
PVAD IQ Software
Ultrasight , Ltd.
MR image reconstruction/enhancement
UltraSight Guidance
Ultrasight , Ltd.
Image Acquisition And/Or Optimization Guided By Artificial Intelligence
Neosoma Brain Mets
🇺🇸Neosoma, Inc.
MR image reconstruction/enhancement
IRISeg
🇺🇸Intuitive Surgical, Inc.
MR image reconstruction/enhancement
Swoop® Portable MR Imaging® System
🇺🇸Hyperfine, Inc.
System, Nuclear Magnetic Resonance Imaging
CogNet AI-MT+
🇺🇸Medcognetics, Inc.
Lesion detection/diagnosis software
Fetal EchoScan (v1.2)
🇫🇷Brightheart
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
ARTAssistant
🇨🇳Manteia Technologies Co., Ltd.
RT auto-contouring
Overjet CBCT Assist
Overjet, Inc.
MR image reconstruction/enhancement
AVIEW Lung Nodule CAD
🇰🇷Coreline Soft Co.,Ltd
Lung Computed Tomography System, Computer-Aided Detection
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
🇺🇸Mighty Oak Medical
MR image reconstruction/enhancement
Cartesion Prime (PCD-1000A/3) V10.21
🇯🇵Canon Medical Systems Corporation
System, Tomography, Computed, Emission
CT VScore+
🇺🇸Canon Medical Informatics, Inc.
System, X-Ray, Tomography, Computed
OEC One CFD
Ge Hualun Medical Systems Co. , Ltd.
Image-Intensified Fluoroscopic X-Ray System, Mobile
Scaida BrainCT-ICH (v1.0)
Mlhealth 360
Triage & notification (CADt)
7600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)
🇮🇹Esaote, S.p.A.
System, Imaging, Pulsed Doppler, Ultrasonic
Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
a2z-Unified-Triage
A2z Radiology Ai, Inc.
Triage & notification (CADt)
Senographe Pristina 3D
🇺🇸GE Healthcare
Digital Breast Tomosynthesis
MAGNETOM Free.Max; MAGNETOM Free.Star
🇨🇳Siemens Shenzhen Magnetic Resonance , Ltd.
System, Nuclear Magnetic Resonance Imaging
