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
5713–5736 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 18, 2012
CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL
K120910 · JAK
GE Medical Systems SCS
Radiology · 84d
Cleared Jun 15, 2012
1.5T 16CH FLEX SPEEDER LARGE
K121362 · MOS
Neocoil, LLC
Radiology · 39d
Cleared Jun 15, 2012
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM
K113613 · IYN
Shantou Institute of Ultrasonic...
Radiology · 192d
Cleared Jun 15, 2012
READY VIEW
K113456 · LLZ
Ge Healthcare (Ge Medical Systems Scs)
Radiology · 207d
Cleared Jun 14, 2012
CHISON DIAGNOSTIC ULTRASOUND SYSTEM
K120801 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 90d
Cleared Jun 14, 2012
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
K120648 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 104d
Cleared Jun 14, 2012
FUSION FLAT PANEL
K113449 · MQB
Icrco, Inc.
Radiology · 206d
Cleared Jun 13, 2012
AQUILION PREMIUM
K120546 · JAK
Toshiba Medical Systems Corporation,...
Radiology · 111d
Cleared Jun 13, 2012
SONIXGPS NEEDLE SENSOR
K111818 · IYO
Ultrasonix Medical Corporation
Radiology · 351d
Cleared Jun 12, 2012
AGILITY
K121328 · IYE
Elekta , Ltd.
Radiology · 40d
Cleared Jun 12, 2012
MULTIARRAY KIT
K121249 · MOS
Paramed S.R.L.
Radiology · 48d
Cleared Jun 12, 2012
DISCOVERY CT750 HD
K120833 · JAK
Ge Medical Systems, LLC
Radiology · 85d
Cleared Jun 08, 2012
BELLYBOARD, SBRT ACCESSORIES
K121545 · LNH
Medtec Inc. Dba Civco Medical Solutions
Radiology · 14d
Cleared Jun 08, 2012
PAX-FLEX3D, PHT-7000
K121412 · OAS
VATECH Co., Ltd.
Radiology · 28d
Cleared Jun 08, 2012
SCENIUM 2.0
K121074 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 60d
Cleared Jun 08, 2012
AERODR STITCHING SYSTEM
K120752 · KPR
Konica Minolta Medical & Graphic, Inc.
Radiology · 88d
Cleared Jun 08, 2012
SIMUPLAN TREATMENT PLANNING SYSTEM
K120551 · MUJ
Simuplan S.L.
Radiology · 106d
Cleared Jun 07, 2012
FLAT PANEL DETECTOR
K121444 · OWB
Canon, Inc. - Medical Equpment Group
Radiology · 23d
Cleared Jun 07, 2012
VIEWFLEX XTRA ICE CATHETER
K121381 · IYO
St Jude Medical
Radiology · 30d
Cleared Jun 06, 2012
TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY
K120731 · JAQ
Varian Medical Systems, Inc.
Radiology · 89d
Cleared Jun 05, 2012
CENTRICITY PACS-IW
K121387 · LLZ
Ge Healthcare Integrated IT Solutions
Radiology · 28d
Cleared Jun 04, 2012
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EB-530US
K121035 · EOQ
Fujifilm Medical System U.S.A., Inc.
Radiology · 60d
Cleared Jun 04, 2012
S-250 PROTON BEAM RADIATION THERAPY SYSTEM
K120676 · LHN
Mevion Medical Systems
Radiology · 91d
Cleared Jun 01, 2012
SR SUITE 1.0
K121345 · KPR
Halifax Biomedical, Inc.
Radiology · 28d