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
4561–4584 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 08, 2015
S-scan
K151668 · LNH
Esaote, S.P.A.
Radiology · 81d
Cleared Sep 08, 2015
CAREVIEW 1800R
K141488 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 460d
Cleared Sep 03, 2015
S12 Digital Color Doppler Ultrasound System
K152396 · IYN
Sonoscape Medical Corp.
Radiology · 10d
Cleared Sep 03, 2015
SpeqRT
K152250 · IYN
Signostics Limited
Radiology · 24d
Cleared Sep 03, 2015
Leksell GammaPlan
K151666 · MUJ
Elekta Instrument AB
Radiology · 76d
Cleared Sep 03, 2015
Model 206 Electrometer/Dosimeter
K150265 · IYE
Cnmc Company Incorporated
Radiology · 211d
Cleared Sep 03, 2015
OPUS 5100 Diagnostic Doppler Ultrasound System
K142982 · IYN
Chang Gung Medical Technology Co., Ltd.
Radiology · 323d
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