FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,570 results
241–264 of 15,570
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 13, 2026
uMI Panvivo (uMI Panvivo)
K253564 · KPS
Shanghai United Imaging Healthcare...
Radiology · 88d
Cleared Feb 11, 2026
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona...
K253049 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 142d
Cleared Feb 11, 2026
AI4CMR v2.0
K252084 · QIH
Ai4medimaging Medical Solutions S.A.
Radiology · 224d
Cleared Feb 11, 2026
ArmSure Fluoroscopic Positioning System
K251992 · OWB
Savfe Co. , Ltd.
Radiology · 229d
Cleared Feb 10, 2026
SpaceOAR Vue System (SV-2101)
K260119 · OVB
Boston Scientific Corporation
Radiology · 27d
Cleared Feb 10, 2026
MI View&GO
K254016 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 57d
Cleared Feb 10, 2026
GEM Flex Coil 16-L Array, 1.5T Receive Only
K252179 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 214d
Cleared Feb 06, 2026
LiveMedica Enterprise PACS
K253927 · LLZ
Live Medica, LLC
Radiology · 60d
Cleared Feb 06, 2026
SIGNA™ Bolt
K253780 · LNH
Ge Medical Systems, LLC
Radiology · 72d
Cleared Feb 06, 2026
Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
K253221 · IYO
Eieling Technology (Shenzhen) Limited
Radiology · 130d
Cleared Feb 06, 2026
LAIA XR
K251577 · LLZ
Augmented Reality Software S.L.
Radiology · 260d
Cleared Feb 06, 2026
Median LCS (internal name) / eyonis LCS (trade name) (1.0)
K251474 · QDQ
Median Technologies
Radiology · 269d
Cleared Feb 05, 2026
Primevision 3D
K253959 · OAS
Dentsply Sirona
Radiology · 57d
Cleared Feb 05, 2026
SIGNA™ Sprint Select
K253779 · LNH
Ge Medical Systems, LLC
Radiology · 71d
Cleared Feb 03, 2026
Diagnostic X-Ray Equipment Model POCT22
K252909 · EHD
Ningbo Runyes Medical Instrument Co.,...
Radiology · 144d
Cleared Feb 02, 2026
TAP2D
K252649 · IZF
Nano-X Imaging , Ltd.
Radiology · 165d
Cleared Jan 30, 2026
RevealAI-Lung
K251769 · POK
Precision Medical Ventures, Inc. Dba...
Radiology · 234d
Cleared Jan 29, 2026
Neurophet AQUA AD Plus
K252496 · QIH
Neurophet., Inc.
Radiology · 174d
Cleared Jan 29, 2026
Surgical Reality Viewer
K252091 · QIH
Medicalvr B.V.
Radiology · 210d
Cleared Jan 28, 2026
Seg Pro V3 (RT-300)
K251306 · QKB
Ever Fortune.Ai, Co., Ltd.
Radiology · 275d
Cleared Jan 27, 2026
BriefCase-Triage
K251195 · QAS
Aidoc Medical , Ltd.
Radiology · 285d
Cleared Jan 26, 2026
Ascent3T Neonatal Magnetic Resonance Imaging System
K253499 · LNH
Eyas Medical Imaging, Inc.
Radiology · 89d
Cleared Jan 23, 2026
3.0T AIR 32CH HNA
K253738 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 60d
Cleared Jan 23, 2026
AccuContour 4.0
K251351 · QKB
Manteia Technologies Co., Ltd.
Radiology · 268d