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 ×
15,589 results
745–768 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 10, 2025
INTRABEAM (700)
K241174 · JAD
Carl Zeiss Meditec, AG
Radiology · 259d
Cleared Jan 09, 2025
Dental Cone-beam Computed Tomography (FinScan F350)
K242805 · OAS
Changzhou Finno Medical Technology...
Radiology · 114d
Cleared Jan 07, 2025
Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit...
K243335 · LNH
Canon Medical Systems Corporation
Radiology · 75d
Cleared Jan 07, 2025
GXR-Series Diagnostic X-Ray System
K242019 · KPR
DRGEM Corporation
Radiology · 181d
Cleared Jan 07, 2025
ApolloHipX (THR.SS.0001)
K241808 · LLZ
Corin U.S.A. Limited
Radiology · 200d
Cleared Jan 07, 2025
uCT 780
K241079 · JAK
Shanghai United Imaging Healthcare...
Radiology · 263d
Cleared Jan 06, 2025
Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E))
K242499 · KPR
Shenzhen?Sontu?Medical?Imaging?Equipm...
Radiology · 137d
Cleared Jan 06, 2025
Soteria E-View
K242488 · JAA
Omega Medical Imaging, LLC
Radiology · 138d
Cleared Jan 06, 2025
Brainomix 360 e-CTA
K242123 · LLZ
Brainomix Limited
Radiology · 171d
Cleared Jan 03, 2025
JLK-ICH
K243363 · QAS
JLK, Inc.
Radiology · 66d
Cleared Jan 03, 2025
INNOVISION-EXII
K242119 · KPR
Dk Medical System
Radiology · 168d
Cleared Jan 03, 2025
syngo.CT Dual Energy
K241757 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 199d
Cleared Jan 03, 2025
Clarify DL
K241350 · LLZ
Ge Medical Systems Israel, Functional...
Radiology · 235d
Cleared Jan 02, 2025
Ezra Flash
K242334 · QIH
Ezra Ai, Inc.
Radiology · 148d
Cleared Jan 02, 2025
Ortho AI
K241696 · QIH
Ortho Ai, LLC
Radiology · 204d
Cleared Dec 27, 2024
BioTraceIO Precision (2.0)
K243084 · QZL
Techsomed Medical Technologies , Ltd.
Radiology · 88d
Cleared Dec 27, 2024
OEC One ASD
K240828 · OXO
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 276d
Cleared Dec 23, 2024
Adora DRFi (04550010)
K242948 · JAA
Nrt X-Ray A/S
Radiology · 89d
Cleared Dec 23, 2024
NIDO Baby Magnetic Resonance Imaging System
K242573 · LNH
Jiangsu Lici Medical Device Co., Ltd.
Radiology · 116d
Cleared Dec 23, 2024
Aquilion ONE (TSX-308A/3) V1.5
K242403 · JAK
Canon Medical Systems Corporation
Radiology · 132d
Cleared Dec 20, 2024
InkSpace Imaging Small Body Array
K243675 · MOS
Inkspace Imaging, Inc.
Radiology · 23d
Cleared Dec 20, 2024
aprevo® Digital Planning
K242599 · LLZ
Carlsmed, Inc.
Radiology · 112d
Cleared Dec 20, 2024
Lightning Viewer
K242362 · LLZ
Nexsys Electronics Inc. Dba Medweb
Radiology · 133d
Cleared Dec 20, 2024
Voluson Expert 18
K242168 · IYN
GE Medical Systems Ultrasound and...
Radiology · 149d