FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
7993–8016 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Aug 03, 2005
AVISO OPHTHALMIC ULTRASOUND SYSTEM
K051851 · IYO
Quantel Medical
Radiology · 26d
Cleared Aug 02, 2005
SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64
K051618 · MOS
Midwest Rf, LLC
Radiology · 46d
Cleared Aug 02, 2005
AS-OBGYN INFORMATION SYSTEM
K051639 · LLZ
As Software, Inc.
Radiology · 43d
Cleared Aug 02, 2005
VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0
K051649 · LLZ
Camtronics Medical Systems
Radiology · 42d
Cleared Aug 02, 2005
STARPACS DENTAL
K051715 · LLZ
Infinitt Co., Ltd.
Radiology · 36d
Cleared Aug 02, 2005
VENTRI
K051855 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 25d
Cleared Aug 02, 2005
ACHIEVA 1.5T & INERA 1.5T FAMILY
K052013 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 7d