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
5353–5376 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 18, 2013
NAOMI-CT
K123332 · OAS
Lk Consulting Group
Radiology · 265d
Cleared Jul 16, 2013
RADVISION
K131428 · MUJ
Acoustic Medsystems, Inc.
Radiology · 60d
Cleared Jul 16, 2013
HERMES MEDICAL IMAGING SUITE V5.3
K131233 · KPS
Hermes Medical Solutions AB
Radiology · 76d
Cleared Jul 15, 2013
PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM, PAX-I DIGITAL EXTRAORAL...
K130585 · MUH
VATECH Co., Ltd.
Radiology · 132d
Cleared Jul 12, 2013
GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
K131514 · IYN
Ge Vingmed Ultrasound AS
Radiology · 45d
Cleared Jul 12, 2013
MIPLATFORM MEDICAL IMAGING SUITE
K131424 · LLZ
Hinacom Software and Technology, Ltd.
Radiology · 56d
Cleared Jul 12, 2013
PADSCAN HD SERIES BLADDER SCANNER
K131227 · IYO
Carenoso Technology Co., Ltd.
Radiology · 73d
Cleared Jul 12, 2013
INGENUITY DIGITAL PET/CT
K123599 · KPS
Philips Healthcare (Cleveland)
Radiology · 233d
Cleared Jul 03, 2013
DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG...
K131106 · MQB
Canon, Inc.
Radiology · 75d
Cleared Jul 03, 2013
2MP COLOR LCD MONITOR, RADIFORCE MX215
K131090 · LLZ
Eizo Corporation
Radiology · 76d
Cleared Jul 03, 2013
NEWTOM VGI AND NEWTOM 5G
K130442 · OAS
Qr S.R.L.
Radiology · 132d
Cleared Jul 02, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR/1417WCA
K130935 · MQB
Rayence Co., Ltd.
Radiology · 89d
Cleared Jun 28, 2013
CODIAGNOSTIX IMPLANT PLANNING SOFTWARE
K130724 · LLZ
Straumann USA
Radiology · 102d
Cleared Jun 28, 2013
ALLURACLARITY XPER FD SERIES X-RAY SYSTEM
K130638 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 109d
Cleared Jun 26, 2013
INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR
K130549 · JAD
Carl Zeiss Meditec, Inc.
Radiology · 114d
Cleared Jun 25, 2013
TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION
K131489 · IYO
Tractus Corporation
Radiology · 33d
Cleared Jun 25, 2013
DDRCRUZE (DIGITAL MOBILE DIAGNOSTIC X-RAY SYSTEM)
K131314 · MQB
Swissray Medical AG
Radiology · 49d
Cleared Jun 21, 2013
DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
K131213 · IYN
Sonoscape Company Limited
Radiology · 53d
Cleared Jun 21, 2013
DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K130833 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 87d
Cleared Jun 20, 2013
DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A
K123106 · KPR
Samsung Electronics Co., Ltd.
Radiology · 261d
Cleared Jun 19, 2013
VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10
K131267 · IYN
Ge Healthcare
Radiology · 47d
Cleared Jun 19, 2013
Z5 DIAGNOSTIC ULTRASOUND SYSTEM
K130695 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 97d
Cleared Jun 18, 2013
IU22 DIAGNOSTIC ULTRASOUND SYSTEM
K130499 · IYN
Philips Ultrasound, Inc.
Radiology · 112d
Cleared Jun 14, 2013
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K130992 · IYE
Philips Medical Systems (Cleveland),...
Radiology · 65d