Cleared in 2026
Radiology AI devices with a 2026 FDA clearance date. The list lags publication of decision summaries, so recent counts keep rising. Information only, never clinical advice.
AV Cardiac CT
🇳🇱Philips Medical Systems Nederland B.V.
System, X-Ray, Tomography, Computed
Magnifico Open (100009900)
🇮🇹Esaote, S.p.A.
System, Nuclear Magnetic Resonance Imaging
QT Scanner 2000 Model A
QT Imaging Holdings, Inc.
System, Imaging, Pulsed Echo, Ultrasonic
Annalise Enterprise
🇦🇺Harrison-AI Medical Pty, Ltd.
Triage & notification (CADt)
Clarius Ejection Fraction AI
🇨🇦Clarius Mobile Health Corp.
MR image reconstruction/enhancement
Ligence Heart
Ligence Uab
MR image reconstruction/enhancement
BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
AI Platform 2.2 (AIP002)
🇺🇸Exo Imaging
MR image reconstruction/enhancement
Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades
🇳🇱Philips Medical Systems Nederland B.V.
System, Nuclear Magnetic Resonance Imaging
MAGNETOM Flow.Ace; MAGNETOM Flow.Plus
🇨🇳Siemens Shenzhen Magnetic Resonance , Ltd.
System, Nuclear Magnetic Resonance Imaging
CARA System
Cara Medical, Ltd.
Interventional Fluoroscopic X-Ray System
Monaco RTP System (6.3)
🇸🇪Elekta Solutions AB
System, Planning, Radiation Therapy Treatment
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, Tomography, Computed, Emission
Delivery Date AI
🇺🇸Ultrasound AI
Radiological Software System For Delivery Date Prediction
AI4CMR v2.0
🇵🇹Ai4medimaging Medical Solutions S.A.
MR image reconstruction/enhancement
MI View&GO
🇺🇸Siemens Medical Solutions USA, Inc.
MR image reconstruction/enhancement
Median LCS (internal name) / eyonis LCS (trade name) (1.0)
Median Technologies
Breast CAD (tomosynthesis)
SIGNA Bolt
🇺🇸Ge Medical Systems, LLC
System, Nuclear Magnetic Resonance Imaging
SIGNA Sprint Select
🇺🇸Ge Medical Systems, LLC
System, Nuclear Magnetic Resonance Imaging
RevealAI-Lung
🇺🇸Precision Medical Ventures, Inc. Dba Revealdx
Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Surgical Reality Viewer
Medicalvr B.V.
MR image reconstruction/enhancement
Neurophet AQUA AD Plus
🇰🇷Neurophet., Inc.
MR image reconstruction/enhancement
Seg Pro V3 (RT-300)
Ever Fortune.Ai, Co., Ltd.
RT auto-contouring
BriefCase-Triage
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
AccuContour 4.0
🇨🇳Manteia Technologies Co., Ltd.
RT auto-contouring
AV Vascular
🇳🇱Philips Medical Systems Nederland B.V.
MR image reconstruction/enhancement
AI-Rad Companion Brain MR
🇩🇪Siemens Healthcare GmbH
MR image reconstruction/enhancement
uCT 780 with uWS-CT-Dual Energy Analysis
🇨🇳Shanghai United Imaging Healthcare Co., Ltd.
System, X-Ray, Tomography, Computed
qXR-Detect
🇮🇳Qure.Ai Technologies
Analyzer, Medical Image
Imagine® Enterprise Suite
Softlink International Private Limited
MR image reconstruction/enhancement
