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
25–48 of 15,570
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 24, 2026
DIANA
K260192 · QIH
ROPCA ApS
Radiology · 183d
Cleared Jul 24, 2026
Accuro 3S
K253452 · IYO
Rivanna Medical, Inc.
Radiology · 291d
Cleared Jul 23, 2026
ImageGrid StreamVue
K262143 · LLZ
Candelis, Inc.
Radiology · 28d
Cleared Jul 23, 2026
Dental Cone-beam Computed Tomography (mDX-15P Series)
K261748 · OAS
Hefei Meyer Optoelectronic...
Radiology · 56d
Cleared Jul 23, 2026
ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/...
K261272 · IYN
Esonic Technology (Wuhan) Co., Ltd.
Radiology · 97d
Cleared Jul 23, 2026
Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro)
K261081 · IYN
Beijing Konted Medical Technology...
Radiology · 113d
Cleared Jul 23, 2026
VELMENI for DENTISTS (V4D) 3D
K254096 · QIH
Velmeni, Inc.
Radiology · 216d
Cleared Jul 21, 2026
ResolutionMD
K260500 · LLZ
ResolutionMD, Inc.
Radiology · 158d
Cleared Jul 21, 2026
CardIQ Suite
K253770 · JAK
GE Medical Systems SCS
Radiology · 237d
Cleared Jul 20, 2026
Hi-D Imaging 4TAVR
K261535 · QIH
Hi-D Imaging AG
Radiology · 73d
Cleared Jul 17, 2026
Cubresa BrainPET
K253963 · OUO
Cubresa, Inc.
Radiology · 218d
Cleared Jul 15, 2026
Better Diagnostics Dental Assist (BDDA) Version 1.0
K260851 · MYN
Better Diagnostics AI Corp.
Radiology · 121d
Cleared Jul 15, 2026
ThinkSono Guidance
K260338 · QJU
ThinkSono GmbH
Radiology · 163d
Cleared Jul 15, 2026
SkeletonPlanner
K260206 · QIH
UPlanner B.V. - Presurgeo
Radiology · 173d
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