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.
Diagnocat
🇺🇸DGNCT, LLC
Analyzer, Medical Image
BIOGRAPH One
🇩🇪Siemens Healthineers AG
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)
🇸🇪Elekta Solutions AB
Accelerator, Linear, Medical
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
🇮🇱Spectrum Dynamics Medical, Ltd.
System, Tomography, Computed, Emission
LOGIQ Totus
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
DS Core Detect
🇺🇸Dentsply Sirona, Inc.
Analyzer, Medical Image
BriefCase-Triage: CARE Multi-triage CT Body
🇮🇱Aidoc Medical , Ltd.
Triage & notification (CADt)
LOGIQ Fortis
🇺🇸GE Medical Systems Ultrasound and Primary Care Diagnostics
System, Imaging, Pulsed Doppler, Ultrasonic
HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System
🇰🇷Samsung Medison Co., Ltd.
System, Imaging, Pulsed Doppler, Ultrasonic
