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
6625–6648 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 09, 2009
PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL
K092747 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 31d
Cleared Oct 09, 2009
VOYAGER COMPACT IMAGING SYSTEM
K092182 · IYO
Ardent Sound, Inc.
Radiology · 80d
Cleared Oct 09, 2009
DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX)
K092103 · EHD
VATECH Co., Ltd.
Radiology · 87d
Cleared Oct 09, 2009
COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO
K090991 · JAK
E-Woo Technology
Radiology · 185d
Cleared Oct 08, 2009
IMAGEGRID RADIOLOGY VIEWER SYSTEM
K092949 · LLZ
Candelis, Inc.
Radiology · 14d
Cleared Oct 08, 2009
MICROSELECTRON HDR V2, MODEL 105.999
K092804 · JAQ
Nucletron Corp.
Radiology · 27d
Cleared Oct 08, 2009
MODIFICATION TO FMRI HARDWARE SYSTEM
K092253 · LNH
Nordicneurolab
Radiology · 72d
Cleared Oct 08, 2009
PMD VIEWER
K092204 · LLZ
Spencer Technologies
Radiology · 78d
Cleared Oct 07, 2009
ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO
K091918 · OWB
Genoray Co., Ltd.
Radiology · 99d
Cleared Oct 02, 2009
MODEL SENTINELLA 102
K092471 · IYX
General Equipment For Medical...
Radiology · 52d
Cleared Oct 02, 2009
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM
K092058 · IYN
Sonosite,Inc.
Radiology · 86d
Cleared Oct 02, 2009
STELLAR FIDUCIAL MARKER, MODEL GFMIA
K092041 · IYE
Stellar Medical, LLC
Radiology · 87d
Cleared Sep 28, 2009
GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM
K092756 · ITX
Ge Vingmed Ultrasound AS
Radiology · 19d
Cleared Sep 28, 2009
SHEATHESISO ULTRASOUND TRANSDUCER COVER
K091828 · ITX
Sheathing Technologies, Inc.
Radiology · 101d
Cleared Sep 24, 2009
PACSCAN PLUS, MODELS 300P AND 300AP
K092637 · ITX
Sonomed, Inc.
Radiology · 28d
Cleared Sep 24, 2009
XIO RTP SYSTEM
K092132 · MUJ
Computerized Medical Systems, Inc.
Radiology · 71d
Cleared Sep 22, 2009
NEUVIZ 16 MULTI-SLICE CT SCANNER SYSTEM
K092742 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 14d
Cleared Sep 22, 2009
EXTEND FRAME SYSTEM, MODEL 1009633
K092083 · IWB
Elekta Instrument AB
Radiology · 75d
Cleared Sep 18, 2009
VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8
K092653 · LHN
Medcom GmbH
Radiology · 21d
Cleared Sep 18, 2009
160MLC OPTION
K092145 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 65d
Cleared Sep 18, 2009
ABVS WORKPLACE
K092067 · LLZ
Siemens AG Medical Solutions
Radiology · 71d
Cleared Sep 18, 2009
OMNIPRO INCLINE
K092018 · IYE
Iba Dosimetry GmbH
Radiology · 74d
Cleared Sep 18, 2009
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K091999 · IYE
Accuray, Inc.
Radiology · 78d
Cleared Sep 18, 2009
CFI ULTRASOUND PROBE DRAPE
K090773 · IYO
Contour Fabricators, Inc.
Radiology · 179d