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
8017–8040 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 22, 2005
CARDIOSTREAM SONOAIM
K051853 · LLZ
Cardiostream, LLC
Radiology · 45d
Cleared Aug 19, 2005
VOLCANO S5 IMAGING SYSTEM, MODEL 804200-001
K051920 · IYO
Volcano Corporation
Radiology · 35d
Cleared Aug 19, 2005
DVT SCANNER
K051980 · JAK
Imaging Sciences Intl., Inc.
Radiology · 29d
Cleared Aug 19, 2005
TEM 3000 HEAD COIL
K052200 · MOS
Mr Instruments, Inc.
Radiology · 7d
Cleared Aug 18, 2005
EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900/859XX
K051337 · OBJ
Volcano Corporation
Radiology · 87d
Cleared Aug 17, 2005
NIO 3MP-21
K051901 · LLZ
Barcoview
Radiology · 35d
Cleared Aug 17, 2005
V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER
K052021 · ITX
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Aug 16, 2005
G-SCAN CERVICAL SPINE COIL
K052077 · MOS
Esaote, S.P.A.
Radiology · 15d
Cleared Aug 15, 2005
FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT
K050320 · ITX
Ascendia Medtech AB
Radiology · 187d
Cleared Aug 15, 2005
EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA...
K051809 · LLZ
Medical Insight A/S
Radiology · 41d
Cleared Aug 15, 2005
ULTRAPACS
K051813 · LLZ
Ultrarad Corporation
Radiology · 41d
Cleared Aug 15, 2005
ENSITE VERISMO SOFTWARE
K051840 · LLZ
St Jude Medical
Radiology · 39d
Cleared Aug 12, 2005
ELEKTA SYNERGY
K051932 · IYE
Elekta, Inc.
Radiology · 30d
Cleared Aug 11, 2005
NIO 2MP-21
K051902 · LLZ
Barcoview
Radiology · 29d
Cleared Aug 11, 2005
MODEL SR-115 PORTABLE X-RAY SYSTEM
K052001 · IZL
Source-Ray, Inc.
Radiology · 17d
Cleared Aug 11, 2005
GE OEC ALTITUDE
K052039 · IZI
Ge Oec Medical Systems
Radiology · 14d
Cleared Aug 11, 2005
SONOSITE HAND-CARRIED ULTRASOUND SYSTEM (C1 SERIES)
K052109 · IYN
Sonosite,Inc.
Radiology · 7d
Cleared Aug 09, 2005
ORTHOSCAN, ORTHOSCAN HD
K051754 · OXO
Orthoscan, Inc.
Radiology · 41d
Cleared Aug 09, 2005
CYBERNIFE STEREOTACTIC RADIOSURGERY SYSTEM
K051941 · MUJ
Accuray, Inc.
Radiology · 22d
Cleared Aug 09, 2005
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
K051967 · KPR
Ge Healthcare
Radiology · 20d
Cleared Aug 09, 2005
SYNGO CIRCULATION
K052029 · JAK
Siemens AG Medical Solutions
Radiology · 13d
Cleared Aug 09, 2005
SONOSCAPE SSI-1000/SSI-5000 ULTRASOUND TRANSDUCERS
K052042 · IYN
Sonoscape Company Limited
Radiology · 12d
Cleared Aug 09, 2005
DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K052113 · IYO
Shenzhen Mindray Bio-Medical...
Radiology · 5d
Cleared Aug 04, 2005
VIEWSEND MEDICAL SYSTEM
K051586 · LLZ
Kenei Co., Ltd.
Radiology · 50d