Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Radiology × Cleared only ×
15,676 results
145–168 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 13, 2026
Rapid Vessel Occlusion (Rapid VO)
K261085 · QAS
Ischemaview
Radiology · 103d
Cleared Jul 10, 2026
Avara Viewer
K262120 · LLZ
Avara Software
Radiology · 17d
Cleared Jul 10, 2026
AI Contouring (VA10A)
K261306 · QKB
Varian Medical Systems
Radiology · 81d
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