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
7633–7656 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 28, 2006
NEUVIZ DUAL MULTI-SLICE CT SCANNER SYSTEM
K062451 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 37d
Cleared Sep 28, 2006
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K062514 · MUJ
Accuray Incorporated
Radiology · 31d
Cleared Sep 27, 2006
CKIS-004A INJECTOR SYNCHRONIZATION OPTION
K061976 · DXT
Toshiba America Medical Systems, In.C
Radiology · 76d
Cleared Sep 27, 2006
CHASE CARDIAC ANALYSIS SYSTEM
K062031 · LLZ
Chase Medical, LP
Radiology · 71d
Cleared Sep 22, 2006
MIMVIEWER
K062163 · LLZ
Mimvista Corp.
Radiology · 56d
Cleared Sep 22, 2006
RESOLUTIONMD, VERSION 1.3
K062164 · LLZ
Calgary Scientific, Inc.
Radiology · 56d
Cleared Sep 22, 2006
TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT
K062618 · IYE
Varian Medical Systems, Inc.
Radiology · 17d
Cleared Sep 22, 2006
MODIFICATION TO SYNGO INSPACE 4D
K062673 · JAK
Siemens AG Medical Solutions
Radiology · 14d
Cleared Sep 21, 2006
MODIFICATION TO HEXAPOD RT COUCH TOP
K062639 · JAI
Medical Intelligence...
Radiology · 15d
Cleared Sep 21, 2006
EP NAVIGATOR SOFTWARE
K062650 · LLZ
Philips Medical Systems
Radiology · 14d
Cleared Sep 20, 2006
LEICA MODEL FL800
K061871 · IZI
Leica Microsystems, Inc.
Radiology · 79d
Cleared Sep 20, 2006
IGUIDE SYSTEM
K062611 · IYE
Medical Intelligence...
Radiology · 15d
Cleared Sep 19, 2006
IQ-SYSTEM PACS SYSTEM
K062488 · LLZ
Image Information Systems, Ltd.
Radiology · 25d
Cleared Sep 18, 2006
GENTLE COLON (REVISION 2.0)
K061532 · LLZ
Rendoscopy, Inc.
Radiology · 108d
Cleared Sep 18, 2006
CONNECT IMAGING PACS
K061972 · LLZ
Connect Imaging, Inc.
Radiology · 67d
Cleared Sep 18, 2006
CRYSTALVIEW R200
K062390 · MQB
Alara, Inc.
Radiology · 33d
Cleared Sep 18, 2006
DIGI-LITE TCD DEVICE
K062578 · IYN
Rimed , Ltd.
Radiology · 18d
Cleared Sep 15, 2006
PULSERA
K061685 · IZL
Philips Medical Systems North America...
Radiology · 92d
Cleared Sep 15, 2006
XPLORER 1100
K062417 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 28d
Cleared Sep 14, 2006
SEDECAL X PLUS LP PLUS
K062335 · KPR
Sedecal., Sa.
Radiology · 35d
Cleared Sep 13, 2006
MAMMOPAD RADIOLUCENT CUSHION
K062141 · IYX
Biolucent, Inc.
Radiology · 48d
Cleared Sep 13, 2006
XPLORER 1590
K062405 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 29d
Cleared Sep 11, 2006
BIOPSY DIGIT-AM
K062039 · IZH
Giotto USA, LLC
Radiology · 54d
Cleared Sep 11, 2006
VOYAGER PACS SYSTEM
K062062 · LLZ
Voyager Imaging
Radiology · 53d