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
4081–4104 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 09, 2016
HYPERION X5
K161900 · OAS
Cefla S.C.
Radiology · 151d
Cleared Dec 08, 2016
CAAS MR 4D Flow
K162376 · LLZ
Pie Medical Imaging BV
Radiology · 106d
Cleared Dec 08, 2016
ProNova SC360 Proton Therapy System
K162246 · LHN
Pronova Solutions, LLC
Radiology · 120d
Cleared Dec 08, 2016
Wireless Digital Flat Panel Detector
K161730 · MQB
Iray Technology (Shanghai) , Ltd.
Radiology · 168d
Cleared Dec 08, 2016
ImagingRing System
K161400 · IYE
Medphoton GmbH
Radiology · 202d
Cleared Dec 07, 2016
GC70
K163115 · KPR
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Dec 07, 2016
CT CoPilot
K161322 · LLZ
Zepmed, LLC
Radiology · 210d
Cleared Dec 05, 2016
DENSEEMAMMO v1.0
K152009 · LLZ
Statlife
Radiology · 503d
Cleared Dec 02, 2016
MEDSYNAPSE Zero Footprint Viewer
K163158 · LLZ
Medsynaptic Private, Ltd.
Radiology · 22d
Cleared Dec 02, 2016
ExactVu High Resolution Micro-Ultrasound System
K162972 · IYO
Exact Imaging
Radiology · 38d
Cleared Dec 02, 2016
Allura Xper FD series and Allura Xper OR Table series
K162859 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 51d
Cleared Dec 02, 2016
EVS 3643, EVS 3643G
K162552 · MQB
DRTECH Corporation
Radiology · 80d
Cleared Dec 02, 2016
GE Lunar DXA Bone Densitometers with enCORE version 17
K161682 · KGI
GE Medical Systems Ultrasound &...
Radiology · 168d
Cleared Dec 02, 2016
FS-500DDR Medical Radiographic X-Ray System
K152813 · KPR
Orich Medical Equipment (Tianjin Co.,...
Radiology · 431d
Cleared Dec 01, 2016
CareView 750Cw/750C X-ray Flat Panel Detectors
K163019 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 31d
Cleared Dec 01, 2016
ClearCheck
K162468 · IYE
Radformation
Radiology · 90d
Cleared Nov 30, 2016
Clarius Ultrasound System
K163138 · IYN
Clarius Mobile Health Corp.
Radiology · 21d
Cleared Nov 30, 2016
TxRx Knee 15 Flare MR Coil 1.5T
K162966 · MOS
Quality Electrodynamics, LLC
Radiology · 37d
Cleared Nov 29, 2016
TxRx Knee 15 Flare MR Coil 3.0T
K163066 · MOS
Quality Electrodynamics, LLC
Radiology · 27d
Cleared Nov 25, 2016
Vantage Galan 3T, MRT-3020, V4.0
K162183 · LNH
Toshibamedical Systems Corporation
Radiology · 113d
Cleared Nov 23, 2016
Allura Xper R9
K162148 · OWB
Philips Medical Systems Nethrlands BV
Radiology · 114d
Cleared Nov 22, 2016
Multix Fusion Max
K162971 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Nov 22, 2016
ViewPoint 6
K162743 · LLZ
GE Medical Systems Ultrasound and...
Radiology · 53d
Cleared Nov 22, 2016
Raycast MammoRx Carbon Fibre Breast Board
K162355 · IYE
Orfit Industries NV
Radiology · 91d