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
4537–4560 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 02, 2015
FACT Medical Imaging Sysytem
K143586 · LLZ
Dexin Medical Imaging Technology Co.,...
Radiology · 258d
Cleared Sep 01, 2015
BOX DICOM Viewer
K151957 · LLZ
Box, Inc.
Radiology · 47d
Cleared Sep 01, 2015
FibroScan
K150239 · IYO
Echosens
Radiology · 211d
Cleared Aug 28, 2015
S8 Exp/S9 Pro Portable Digital Color Doppler Ultrasound System
K152164 · IYN
Sonoscape Medical Corp.
Radiology · 25d
Cleared Aug 27, 2015
16 ch Tx/Rx Knee SPEEDER
K151753 · MOS
Quality Electrodynamics, LLC
Radiology · 59d
Cleared Aug 26, 2015
S9 Portable Digital Color Doppler Ultrasound System
K152165 · IYN
Sonoscape Medical Corp.
Radiology · 23d
Cleared Aug 26, 2015
EDLENi Intra-Oral Sensor
K150823 · MUH
Edlen Imaging, LLC
Radiology · 152d
Cleared Aug 21, 2015
CS 8100SC, CS8100SC Access
K151087 · MUH
Trophy
Radiology · 120d
Cleared Aug 20, 2015
HealthMyne PACS
K152186 · LLZ
Healthmyne, Inc.
Radiology · 15d
Cleared Aug 19, 2015
FUJIFILM SonoSite X-Porte Ultrasound System
K152209 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 12d
Cleared Aug 19, 2015
CS 3D Imaging
K151837 · LLZ
Trophy
Radiology · 44d
Cleared Aug 19, 2015
Corporate Dental Imaging (CDI) Application
K151371 · LLZ
U.S. Army Dental Command (Dencom)
Radiology · 90d
Cleared Aug 19, 2015
ScandiDos Delta4 Phantom+
K151180 · IYE
Scandidos AB
Radiology · 107d
Cleared Aug 17, 2015
VesselNavigator Rel. 1.0
K151598 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 66d
Cleared Aug 17, 2015
EDOSE
K150767 · IYE
Guangzhou Raydose Software...
Radiology · 146d
Cleared Aug 17, 2015
SOPIX
K142995 · MUH
Sopro - Acteon Group
Radiology · 305d
Cleared Aug 14, 2015
Low Dose CT Lung Cancer Screening Option for Qualified GE Systems
K151372 · JAK
Ge Medical Systems, LLC
Radiology · 85d
Cleared Aug 13, 2015
Respiratory Gating for Scanners
K151533 · JAK
Varian Medical Systems, Inc.
Radiology · 66d
Cleared Aug 13, 2015
syngo.via RT Image Suite
K151380 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 83d
Cleared Aug 12, 2015
Synapse Cardiovascular
K151859 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 35d
Cleared Aug 12, 2015
RS80A Diagnostic Ultrasound System
K151663 · IYN
Samsung Medison Co., Ltd.
Radiology · 54d
Cleared Aug 11, 2015
McKesson Cardiology
K151850 · LLZ
Mckesson Israel , Ltd.
Radiology · 35d
Cleared Aug 11, 2015
syngo.CT Dual Energy
K150757 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 141d
Cleared Aug 11, 2015
syngo.CT Single Source Dual Energy
K150745 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 141d