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
5761–5784 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jun 01, 2012
SYNAPSE 3D NODULE ANALYSIS
K120679 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 87d
Cleared Jun 01, 2012
VANTAGE TITAN
K120638 · LNH
Toshibamedical Systems Corporation
Radiology · 92d
Cleared May 31, 2012
GUIDEMIA
K121466 · LLZ
Guidemia Technologies, LLC
Radiology · 14d
Cleared May 31, 2012
SPECTRUM V.0
K121023 · LLZ
Intrinsic Medical Imaging
Radiology · 57d
Cleared May 30, 2012
SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE
K120882 · IYO
Bard Access Systems, Inc.
Radiology · 68d
Cleared May 30, 2012
SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM
K113739 · LLZ
Materialise Dental NV
Radiology · 162d
Cleared May 24, 2012
MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS...
K121239 · LNH
Optoacoustics, Ltd.
Radiology · 30d
Cleared May 24, 2012
PAX-DUO3D PLUS, PCT-5000
K121236 · OAS
VATECH Co., Ltd.
Radiology · 30d
Cleared May 24, 2012
LEKSELL GAMMA KNIFE PERFEXION
K120811 · IWB
Elekta Instrument AB
Radiology · 69d
Cleared May 23, 2012
MYLABSOGNO
K121384 · IYN
Esaote, S.P.A.
Radiology · 15d
Cleared May 23, 2012
AERODR X70
K121109 · KPR
Konica Minolta Medical & Graphic, Inc.
Radiology · 41d
Cleared May 23, 2012
SOMATOM DEFINITION EDGE
K120579 · JAK
Siemens Medical Systems, Inc.
Radiology · 86d
Cleared May 23, 2012
VANTAGE TITAN 3T
K120487 · LNH
Toshibamedical Systems Corporation
Radiology · 96d
Cleared May 23, 2012
SOMATOM PERSPECTIVE
K113287 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 198d
Cleared May 22, 2012
UNIVERSAL DIGITAL INTERFACE (UDI) 1717
K112527 · MQB
Meridian Medical Systems, LLC
Radiology · 265d
Cleared May 22, 2012
VIEWRAY SYSTEM
K111862 · IYE
Viewray, Incorporated
Radiology · 327d
Cleared May 17, 2012
ACUSON S3000 DIAGNOSTIC ULTRASOUND SYSTEM
K121138 · IYN
Siemens Medical Solution
Radiology · 34d