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
7273–7296 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 03, 2007
SUNIRAY 5.2
K072665 · LLZ
Orangedental GmbH & Co. KG
Radiology · 12d
Cleared Oct 02, 2007
AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM
K072606 · JAK
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Oct 01, 2007
MONACO RTP SYSTEM
K071938 · MUJ
Computerized Medical Systems, Inc.
Radiology · 80d
Cleared Oct 01, 2007
GATECT-RT
K072171 · IYE
Vision RT Limited
Radiology · 56d
Cleared Oct 01, 2007
MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM
K072468 · KPS
Spectrum Dynamics , Ltd.
Radiology · 27d
Cleared Sep 26, 2007
MIM 4.1 (SEASTAR)
K071964 · LLZ
Mimvista Corp.
Radiology · 72d
Cleared Sep 26, 2007
POIINT OF CARE STRANDING SYSTEM, MODE 1004-00
K072296 · KXK
Theragenics Corp.
Radiology · 40d
Cleared Sep 26, 2007
ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3
K072517 · IYO
Boston Scientific Corp
Radiology · 19d
Cleared Sep 25, 2007
OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM
K072392 · IZL
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Sep 25, 2007
SENOSONIX ULTRASOUND BREAST BIOPSY SYSTEM
K072541 · ITX
Senorx, Inc.
Radiology · 15d
Cleared Sep 21, 2007
PLANMECA PROONE
K072244 · MUH
Planmeca Oy
Radiology · 39d
Cleared Sep 21, 2007
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K072279 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 36d
Cleared Sep 21, 2007
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K072504 · IYE
Accuray Incorporated
Radiology · 15d
Cleared Sep 20, 2007
EMBRACE GEL
K072515 · MUI
Orison Corporation
Radiology · 13d
Cleared Sep 18, 2007
EOS
K071546 · KPR
Biospace Med
Radiology · 104d
Cleared Sep 18, 2007
NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM
K072357 · MUH
Afp Imaging Corp.
Radiology · 27d
Cleared Sep 14, 2007
SIEMENS DIAGNOSTIC ULTRASOUND SYSTEMS
K072090 · IYN
Siemens Medical Solutions USA, Inc.,...
Radiology · 46d
Cleared Sep 14, 2007
GE LUNAR DPX & PRODIGY SERIES DEXA BONE DENSITOMETERS WITH MOBILE KIT
K072439 · KGI
Ge Medical Systems Ultrasound and...
Radiology · 15d
Cleared Sep 14, 2007
INTEGRATED BRACHYTHERAPY UNIT - DIGITAL
K072445 · KPQ
Nucletron Corp.
Radiology · 15d
Cleared Sep 11, 2007
FIDUCIAL MARKERS
K071614 · IYE
Civco
Radiology · 90d
Cleared Sep 11, 2007
COR ANALYZER II, MODEL V1.7
K072242 · LLZ
Rcadia Medical Imaging , Ltd.
Radiology · 29d
Cleared Sep 07, 2007
SPY FLUORESCENT IMAGING SYSTEM
K072222 · IZI
Novadaq Technologies, Inc.
Radiology · 28d
Cleared Sep 05, 2007
1.5T MRGFUS PELVIC COIL
K071966 · MOS
Insightec Txsonics, Inc.
Radiology · 51d
Cleared Sep 05, 2007
DC-6 DIAGNOSTIC ULTRASOUND SYSTEM
K072164 · ITX
Shenzhen Mindray Bio-Medical...
Radiology · 30d