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
1129–1152 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 13, 2024
QOCA® image Smart RT Contouring System
K231855 · QKB
Quanta Computer, Inc.
Radiology · 235d
Cleared Feb 12, 2024
Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)
K233401 · IYO
Eieling Technology Limited
Radiology · 131d
Cleared Feb 12, 2024
Mimics Cardiac Planner
K233217 · LLZ
Materialise NV
Radiology · 137d
Cleared Feb 08, 2024
XVbeam2000
K233914 · EHD
Shenzhen Xpectvision Technology Co.,...
Radiology · 58d
Cleared Feb 08, 2024
HealthFLD
K233080 · JAK
Nano-X AI , Ltd.
Radiology · 135d
Cleared Feb 08, 2024
Leksell GammaPlan (LGP)
K232854 · IWB
Elekta Solutions AB
Radiology · 146d
Cleared Feb 08, 2024
neuro42 MRI System
K232644 · LNH
Neuro42, Inc.
Radiology · 162d
Cleared Feb 08, 2024
Aid-U
K231662 · LLZ
Iaid
Radiology · 246d
Cleared Feb 06, 2024
5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP,...
K233897 · PGY
Shenzhen Beacon Display Technology...
Radiology · 57d
Cleared Feb 05, 2024
Ziehm Vision RFD
K240099 · OWB
Ziehm Imaging GmbH
Radiology · 24d
Cleared Feb 05, 2024
Smart Fit Knee 3.0T
K233600 · MOS
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 88d
Cleared Feb 05, 2024
Viz HDS, Viz Volume Plus, Viz ICH+
K232363 · QIH
Viz. Ai, Inc.
Radiology · 182d
Cleared Feb 01, 2024
Kelowna GYN and Crook Prostate Templates
K232949 · JAQ
Varian Medical Systems, Inc.
Radiology · 134d
Cleared Feb 01, 2024
Augmented Reality Application
K232339 · LLZ
Sira Medical, Inc.
Radiology · 181d
Cleared Feb 01, 2024
CAAS MR Solutions
K232007 · LLZ
Pie Medical Imaging BV
Radiology · 210d
Cleared Jan 31, 2024
CEPHX- Cephalometric Analysis Software
K231396 · LLZ
Orca Dental AI , Ltd.
Radiology · 261d
Cleared Jan 30, 2024
Ziehm Vision FD
K240020 · OWB
Ziehm Imaging GmbH
Radiology · 28d
Cleared Jan 26, 2024
Ziehm Solo FD
K234109 · OWB
Ziehm Imaging GmbH
Radiology · 30d
Cleared Jan 25, 2024
BreView
K233714 · LLZ
GE Medical Systems SCS
Radiology · 66d
Cleared Jan 24, 2024
Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System
K233195 · IYN
Canon Medical Systems Corporation
Radiology · 118d
Cleared Jan 24, 2024
Axial3D Cloud Segmentation Service
K231607 · LLZ
Axial Medical Printing Limited
Radiology · 237d
Cleared Jan 19, 2024
SIGNA Champion
K233728 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 59d
Cleared Jan 19, 2024
Rapid ASPECTS (v3)
K232156 · POK
Ischemaview, Inc.
Radiology · 183d
Cleared Jan 18, 2024
NemoScan
K232698 · QIH
Software Nemotec S.L.
Radiology · 135d