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
7585–7608 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 20, 2006
D-SPECT CARDIAC SCANNER SYSTEM
K062450 · KPS
Spectrum Dynamics , Ltd.
Radiology · 59d
Cleared Oct 20, 2006
E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50
K062647 · OWB
Omega Medical Imaging, Inc.
Radiology · 44d
Cleared Oct 20, 2006
BIOLUCENT APPLICATOR KIT
K062830 · JAQ
Biolucent, Inc.
Radiology · 30d
Cleared Oct 19, 2006
MEDHOT MTI 2000 THERMAL IMAGING SYSTEM
K063047 · LHQ
Medhot Thermal Imaging, Inc.
Radiology · 15d
Cleared Oct 18, 2006
CENTARISONE RIS/PACS
K063037 · LLZ
Centarisone, LLC
Radiology · 15d
Cleared Oct 18, 2006
SYNGO LUNG CAD
K063877 · OEB
Siemens Medical Solutions USA, Inc.
Radiology · 6d
Cleared Oct 13, 2006
CR 85-X
K062742 · MQB
Agfa Corporation
Radiology · 29d
Cleared Oct 13, 2006
CTL-63 AND CTL-128 SPINE ARRAY COILS
K062767 · MOS
Invivo Corporation
Radiology · 28d
Cleared Oct 06, 2006
5 MEGAPIXEL MONOCHROME LCD MONITOR, RADIFORCE GS510
K062054 · LLZ
Eizo Nanao Corporation
Radiology · 78d
Cleared Oct 06, 2006
ORTHOXP
K062634 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 30d
Cleared Oct 05, 2006
ACCUSOFT, ACCUSOFT XL
K062032 · MUJ
Direx Systems Corp.
Radiology · 79d
Cleared Oct 05, 2006
SYNGO DUAL ENERGY
K062351 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 55d
Cleared Oct 05, 2006
BRANSIST SAFIRE
K062360 · IZI
Shimadzu Corp.
Radiology · 52d
Cleared Oct 05, 2006
QANGIO CT
K062386 · JAK
Medis Medical Imaging Systems BV
Radiology · 51d
Cleared Oct 05, 2006
BELMAX CM MODEL X168
K062529 · MUH
Takara Belmont USA, Inc.
Radiology · 37d
Cleared Oct 05, 2006
ECHELON SHOULDER COIL
K062556 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 36d
Cleared Sep 29, 2006
XPLORER 1600 PLUS
K062586 · MQB
Imaging Dynamics Company , Ltd.
Radiology · 28d
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