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
6049–6072 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 05, 2011
GLIASITE RTS
K111931 · KXK
Isoray Medical, Inc.
Radiology · 28d
Cleared Aug 05, 2011
IBIS EXPLORER AND MARKUP SOFTWARE
K111319 · LLZ
Medqia
Radiology · 87d
Cleared Aug 05, 2011
SEDECAL MOBILE DIGITAL DIAGNOSTIC X-RAY
K101517 · IZL
Sedecal., Sa.
Radiology · 429d
Cleared Aug 04, 2011
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER
K111043 · OBJ
Boston Scientific Corp
Radiology · 111d
Cleared Aug 02, 2011
WV3000T DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM
K110801 · MQB
Direct Digital Imaging Technology...
Radiology · 132d
Cleared Aug 02, 2011
VANTAGE TITAN 3T
K102489 · LNH
Toshiba Medical Systems Corporation,...
Radiology · 336d
Cleared Jul 29, 2011
HEARTNAVIGATOR RELEASE 1
K111245 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 87d
Cleared Jul 28, 2011
VITREAVIEW SOFTWARE 6.1
K111892 · LLZ
Vital Images, Inc.
Radiology · 23d
Cleared Jul 28, 2011
INTELLISPACE PACS 4.X
K111804 · LLZ
Philips Healthcare Informatics, Inc.
Radiology · 31d
Cleared Jul 28, 2011
MRI-Q SYSTEM
K111222 · LLZ
Resonance Health Analysis Services...
Radiology · 87d
Cleared Jul 28, 2011
XELIS 3D
K103130 · LLZ
Infinitt Co., Ltd.
Radiology · 279d
Cleared Jul 26, 2011
LOGIQ S8
K111582 · IYN
Ge Healthcare
Radiology · 50d
Cleared Jul 26, 2011
INTEGRATED INNOVA - S5I SYSTEM OPTION
K111209 · IZI
Ge Healthcare
Radiology · 88d
Cleared Jul 26, 2011
PICA WHOLE-BODY MRI SYSTEM
K110942 · LNH
Time Medical Limited
Radiology · 113d
Cleared Jul 22, 2011
MYLABSEVEN, MYLABALPHA
K111302 · IYN
Esaote, S.P.A.
Radiology · 74d
Cleared Jul 22, 2011
ROTOGRAPH EVO 3D
K111152 · MUH
Villa Sistemi Medicali S.P.A.
Radiology · 88d
Cleared Jul 22, 2011
LOGIQ E9
K110943 · IYN
Ge Healthcare
Radiology · 109d
Cleared Jul 20, 2011
AXXENT RADIATION SHIELD - RIGID
K111299 · JAD
Xoft, an Icad Company
Radiology · 72d
Cleared Jul 20, 2011
COMMUNIFY PACS VIEWER
K110797 · LLZ
Flying Squirrel Storage, LLC
Radiology · 120d
Cleared Jul 20, 2011
OPTIMA CT660
K110227 · JAK
Ge Medical Systems, LLC
Radiology · 176d
Cleared Jul 19, 2011
MOBILEDIAGNOST WDR
K111725 · IZL
Sedecal., Sa.
Radiology · 29d
Cleared Jul 19, 2011
OPTIMA XR120
K111304 · IXL
Ge Medical Systems, LLC
Radiology · 71d
Cleared Jul 19, 2011
BEL-CAT
K101181 · OAS
Takara Belmont Corp.
Radiology · 448d
Cleared Jul 15, 2011
E-CUBE 9
K111864 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 15d