FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
73–96 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 10, 2026
SmartCT (R3.0 (L10))
K253670 · OWB
Philips Medical Systems B.V.
Radiology · 231d
Cleared Jul 09, 2026
3D-Anywhere
K253899 · LLZ
Provect.AI
Radiology · 216d
Cleared Jul 08, 2026
Virtual Cone (1.0)
K260750 · MUJ
Varian Medical Systems, Inc.
Radiology · 124d
Cleared Jul 08, 2026
CXRDetectAI
K253751 · QFM
Neurocareai, Inc. (Dba Savelife.Ai)
Radiology · 225d
Cleared Jul 07, 2026
InferOperate Suite
K260973 · QIH
Beijing Infervision Healthcare...
Radiology · 105d
Cleared Jul 07, 2026
Pulmonex II Xenon System (132-503)
K253942 · IYT
Mirion Technologies (Capintec), Inc.
Radiology · 210d
Cleared Jul 06, 2026
INDIRA CLOUD VIEWER
K261465 · LLZ
INDIGO TECHNOLOGIES
Radiology · 63d
Cleared Jul 02, 2026
OncoStudio
K260528 · QKB
Oncosoft. Inc.,
Radiology · 135d
Cleared Jul 02, 2026
Koios DS (3.8)
K253884 · POK
Koios Medical, Inc.
Radiology · 210d
Cleared Jun 26, 2026
MammoScreen® (5)
K260714 · QDQ
Therapixel
Radiology · 113d
Cleared Jun 25, 2026
MiPACS V5 (1.0.0)
K260231 · LLZ
Apryse Software Corp
Radiology · 150d
Cleared Jun 25, 2026
syngo.CT Coronary Cockpit
K253786 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 211d
Cleared Jun 25, 2026
IntraOp Alignment System
K253216 · SIN
Alphatec Spine, Inc.
Radiology · 269d
Cleared Jun 24, 2026
Enhanced Boundary for PCCT
K253560 · JAK
Ge Medical Systems, LLC
Radiology · 219d
Cleared Jun 22, 2026
CMN Capillary Function with Oncology Virtual Expert
K260316
Cercare Medical A/S
Radiology · 143d
Cleared Jun 22, 2026
Perfusion Measurement Platform v1
K253421 · LLZ
Quantified Imaging Limited
Radiology · 264d
Cleared Jun 18, 2026
Synapse PACS (7.6.0)
K261713 · QIH
Fujifilm Healthcare Americas Corporation
Radiology · 27d
Cleared Jun 18, 2026
VIVIX-S 4386W (FXRD-4386WA)
K260820 · MQB
Vieworks Co., Ltd.
Radiology · 97d
Cleared Jun 18, 2026
Vascular Assist Occlusion Triage (VAOT) (v1.0)
K260729 · QAS
GuideAI Health
Radiology · 104d
Cleared Jun 18, 2026
ARTHUR
K260190 · IYO
ROPCA ApS
Radiology · 147d
Cleared Jun 18, 2026
MAMMOMAT B.brilliant (11372950)
K253678 · MUE
Siemens Medical Solutions USA, Inc.
Radiology · 209d
Cleared Jun 18, 2026
Portable DR Imaging System
K253058 · IZL
Shantou Institute of Ultrasonic...
Radiology · 269d
Cleared Jun 18, 2026
RadOncAI
K253050 · MUJ
Informai
Radiology · 269d
Cleared Jun 17, 2026
Non-Sterile Ultrasound Gel Sterile Ultrasound Gel
K253255 · MUI
Foshan Pingchuang Medical Technology...
Radiology · 261d