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
4945–4968 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 19, 2014
NOMAD MD 75K V HANDHELD X-RAY SYSTEM
K140723 · IZL
Aribex, Inc.
Radiology · 151d
Cleared Aug 14, 2014
SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT
K140232 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 196d
Cleared Aug 07, 2014
BREAST VOLUME NAVIGATOR
K141870 · IYN
Metritrack, LLC
Radiology · 27d
Cleared Aug 07, 2014
ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM
K141846 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Aug 07, 2014
SAGITTILT
K141787 · IYE
Orfit Industries NV
Radiology · 36d
Cleared Aug 07, 2014
ECLIPSE TREATMENT PLANNING SYSTEM
K141283 · MUJ
Varian Medical Systems, Inc.
Radiology · 83d
Cleared Aug 07, 2014
LCD MONITOR
K140956 · LNH
Nordicneurolab
Radiology · 115d
Cleared Aug 07, 2014
TITAN 11
K133695 · KPR
Gemss Medical Systems Co., Ltd.
Radiology · 247d
Cleared Aug 07, 2014
TON-95LH, PAX-I3D ORTHO
K132983 · OAS
VATECH Co., Ltd.
Radiology · 318d
Cleared Aug 06, 2014
SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS
K141336 · JAQ
Varian Medical Systems, Inc.
Radiology · 77d
Cleared Aug 06, 2014
NORAS OR HEAD HOLDER FLEXIBILITY
K133506 · MOS
Noras Mri Products GmbH
Radiology · 265d
Cleared Aug 05, 2014
ORTOMED
K131348 · LLZ
Infomed Servicios Informaticos S.L.
Radiology · 452d
Cleared Aug 04, 2014
MEDICAL LCD MONITOR
K141891 · PGY
Kostec Co., Ltd.
Radiology · 21d
Cleared Aug 04, 2014
LOGIQ V5/LOGIQ V3
K141768 · IYN
Ge Healthcare
Radiology · 34d
Cleared Aug 01, 2014
JUSHA-M33C LCD MONITOR
K141690 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 39d
Cleared Aug 01, 2014
JUSHA-C33C LCD MONITOR
K141684 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 39d
Cleared Aug 01, 2014
JUSHA-C61 LCD MONITOR
K141679 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 39d
Cleared Aug 01, 2014
VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)
K141302 · LLZ
Vital Images, Inc.
Radiology · 74d
Cleared Aug 01, 2014
REMOTEYE VIEWER
K141061 · LLZ
Neologica S.R.L.
Radiology · 99d
Cleared Aug 01, 2014
PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR
K140551 · MQB
Perkinelmer, Inc.
Radiology · 150d
Cleared Jul 31, 2014
3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE
K141832 · MOS
Neocoil, LLC
Radiology · 24d
Cleared Jul 31, 2014
DIGIARC 100AU+
K141672 · OXO
Beijing East Whale Imaging Technology...
Radiology · 38d
Cleared Jul 31, 2014
ENDOSIZE
K141475 · LLZ
Therenva Sas
Radiology · 57d
Cleared Jul 30, 2014
ENCOMPASS
K141130 · MUH
Panoramic Corp.
Radiology · 90d