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
6241–6264 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 31, 2011
COR ANALYZER
K110071 · LLZ
Rcadia Medical Imaging , Ltd.
Radiology · 21d
Cleared Jan 31, 2011
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
K103677 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 46d
Cleared Jan 31, 2011
SYNAPSE 3D CARDIAC TOOLS
K103465 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 68d
Cleared Jan 28, 2011
NEUCOLONCARE
K110077 · LLZ
Neusoft Medical Systems Co., Ltd.
Radiology · 17d
Cleared Jan 26, 2011
OMNIVISION
K110040 · LLZ
Modern Module, Inc.
Radiology · 20d
Cleared Jan 26, 2011
SEDECAL
K103522 · IZL
Sedecal., Sa.
Radiology · 56d
Cleared Jan 25, 2011
Q-STATION
K103815 · LLZ
Philips Ultrasound, Inc.
Radiology · 27d
Cleared Jan 25, 2011
PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER
K103616 · IYE
Aktina Medical Physics Corp.
Radiology · 46d
Cleared Jan 24, 2011
VIZION DR
K102123 · KPR
Viztek, Inc.
Radiology · 179d
Cleared Jan 21, 2011
REALEYE MODEL VCPS
K100625 · IYE
Navotek Medical, Ltd.
Radiology · 323d
Cleared Jan 20, 2011
TERASON T3200 ULTRASOUND SYSTEM
K110020 · ITX
Teratech Corp.
Radiology · 17d
Cleared Jan 20, 2011
MOBIUS ULTRASOUND IMAGING SYSTEM
K102153 · IYO
Mobisante, Inc.
Radiology · 174d
Cleared Jan 19, 2011
WBR XPRESS PET
K103710 · KPS
Ultraspect , Ltd.
Radiology · 30d
Cleared Jan 14, 2011
TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K103182 · LLZ
Genoray Co., Ltd.
Radiology · 78d
Cleared Jan 12, 2011
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM
K103645 · ITX
Toshiba Medical Systems Corporation,...
Radiology · 30d
Cleared Jan 12, 2011
BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV)
K103394 · IYE
Varian Medical Systems, Oncology Systems
Radiology · 54d
Cleared Jan 12, 2011
DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR)
K103365 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 56d
Cleared Jan 12, 2011
DIGITAL COLOR DOPPLER ULTRASOUND IMAGAING SYSTEM
K103144 · IYN
Shantou Institute of Ultrasonic...
Radiology · 79d
Cleared Jan 12, 2011
VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM
K102915 · MUJ
Viewray, Incorporated
Radiology · 103d
Cleared Jan 11, 2011
SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS
K103275 · MOS
Siemens Medical Solutions USA, Inc.
Radiology · 67d
Cleared Jan 07, 2011
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
K103512 · IZH
Hologic, Inc.
Radiology · 38d
Cleared Jan 07, 2011
6250 ULTRASOUND SYTEMS
K103152 · IYN
Esaote, S.P.A.
Radiology · 73d
Cleared Jan 06, 2011
THE ADDITION
K102683 · MUI
Ob The-Addition, LLC
Radiology · 111d
Cleared Jan 05, 2011
THE SONOACE R5 DIAGNOSTIC ULTRASOUND SYSTEM
K103722 · ITX
Medison Co., Ltd.
Radiology · 15d