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
3025–3048 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 24, 2019
Discovery XR656 HD with VolumeRad
K191699 · KPR
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 29d
Cleared Jul 23, 2019
Vantage Orian 1.5T, MRT-1550, V4.5
K191662 · LNH
Canon Medical Systems Corporation
Radiology · 32d
Cleared Jul 19, 2019
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0
K191467 · IYN
Canon Medical Systems Corporation
Radiology · 46d
Cleared Jul 19, 2019
syngo.via MI Workflows VB40A, Scenium
K191309 · LLZ
Siemens Medical Soultions USA, Inc.
Radiology · 66d
Cleared Jul 19, 2019
SpaceOAR Vue Hydrogel
K182971 · OVB
Augmenix, Inc.
Radiology · 266d
Cleared Jul 16, 2019
Orthophos S
K191616 · OAS
Dentsply Sirona
Radiology · 28d
Cleared Jul 12, 2019
iNtuition-Structural Heart Module
K191585 · LLZ
Terarecon,Inc.
Radiology · 28d
Cleared Jul 12, 2019
MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic...
K191050 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Jul 12, 2019
VERITON CT whole body SPECT/CT system
K190457 · KPS
Spectrum Dynamics Medical, Ltd.
Radiology · 137d
Cleared Jul 11, 2019
Unifi Workspace v1.0.0
K190694 · LLZ
Hologic, Inc.
Radiology · 115d
Cleared Jul 10, 2019
Vave Personal Ultrasound System
K191541 · IYO
Vave Health, Inc.
Radiology · 29d
Cleared Jul 10, 2019
Identify
K190137 · IYE
Varian Medical Systems, Inc.
Radiology · 162d
Cleared Jul 10, 2019
Full Digital Colour Doppler Ultrasonic Diagnostic System
K183041 · IYN
Wuhan Zoncare Bio-medical Electronics...
Radiology · 251d
Cleared Jul 10, 2019
DeepCT
K182875 · QAS
Deep01 Limited
Radiology · 271d
Cleared Jul 08, 2019
BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device
K191580 · JAQ
Varian Medical Systems, Inc.
Radiology · 24d
Cleared Jul 08, 2019
RayCare 2.3
K191384 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 46d
Cleared Jul 08, 2019
nView system 1
K190064 · OWB
Nview Medical, Inc.
Radiology · 174d
Cleared Jul 05, 2019
syngo.MR Applications
K182904 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 262d
Cleared Jul 05, 2019
Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE
K182901 · JAK
Canon Medical Systems Corporation
Radiology · 262d
Cleared Jul 03, 2019
Biopsy Positioner
K191495 · IZH
Fujifilm Corporation
Radiology · 28d
Cleared Jul 03, 2019
syngo.CT Dual Energy
K191468 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Jul 03, 2019
CMDR 2CW (Multiple models)
K191451 · IZL
Minxray, Inc.
Radiology · 33d
Cleared Jul 03, 2019
Koios DS for Breast
K190442 · POK
Koios Medical, Inc.
Radiology · 128d
Cleared Jul 02, 2019
5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500
K191137 · PGY
Jvckenwood Corporation
Radiology · 64d