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
5281–5304 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 30, 2013
BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY
K132097 · JAQ
Best Medical International, Inc.
Radiology · 84d
Cleared Sep 26, 2013
ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEM
K132654 · IYO
Siemens Medical Solutions USA, Inc....
Radiology · 31d
Cleared Sep 26, 2013
ESTEYA
K132092 · JAD
Nucletron B.V.
Radiology · 83d
Cleared Sep 26, 2013
PROTURA COUCH SOFTWARE
K132084 · JAI
Med-Tec, Inc. D/B/A Civco Medical...
Radiology · 83d
Cleared Sep 26, 2013
SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)
K131885 · MUE
GE Medical Systems SCS
Radiology · 93d
Cleared Sep 26, 2013
NANOR AND EFFICAST/NANOR HYBRID THERMOPLASTIC MATERIALS
K131795 · IYE
Orfit Industries NV
Radiology · 100d
Cleared Sep 26, 2013
AIRO CT SYSTEM
K131431 · JAK
Mobius Imaging, LLC
Radiology · 132d
Cleared Sep 25, 2013
XVI R5.0
K131965 · IYE
Elekta Limited
Radiology · 90d
Cleared Sep 25, 2013
ECLIPSE TREATMENT PLANNING SYSTEM
K131891 · MUJ
Varian Medical Systems, Inc.
Radiology · 92d
Cleared Sep 25, 2013
NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD)
K131873 · LLZ
MethodSense, Inc.
Radiology · 93d
Cleared Sep 24, 2013
AIXPLORER
K132274 · IYN
Supersonic Imagine
Radiology · 64d
Cleared Sep 24, 2013
AIXPLORER
K132171 · IYN
Supersonic Imagine
Radiology · 71d
Cleared Sep 24, 2013
VOLUSON I/E
K131937 · IYN
Ge Healthcare
Radiology · 89d
Cleared Sep 24, 2013
BRILLIANCE ICT
K131773 · JAK
Philips Healthcare (Cleveland)
Radiology · 99d
Cleared Sep 24, 2013
GE ECHOPAC
K131685 · LLZ
Ge Vingmed Ultrasound AS
Radiology · 106d
Cleared Sep 17, 2013
CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT
K131977 · LLZ
Ge Healthcare
Radiology · 81d
Cleared Sep 17, 2013
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K131830 · IYO
Edan Instruments, Inc.
Radiology · 89d
Cleared Sep 17, 2013
EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER
K131161 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 146d
Cleared Sep 17, 2013
DIGITAL FLAT PANEL X-RAY DETECTOR
K131114 · MQB
Rayence Co., Ltd.
Radiology · 148d
Cleared Sep 12, 2013
QXLINK
K132302 · LLZ
Vieworks Co., Ltd.
Radiology · 50d
Cleared Sep 06, 2013
FIRECR DENTALIMAGING SYSTEM
K131442 · MUH
3Disc Americas
Radiology · 109d
Cleared Sep 06, 2013
JUSHA-C31 MEDICAL DISPLAY
K131389 · LLZ
Nanjing Jusha Display Technology Co.,...
Radiology · 115d
Cleared Sep 06, 2013
XPERCT REL. 3
K130893 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 158d
Cleared Sep 05, 2013
KOSTEC MEDICAL GRADE LDC MONITORS
K123944 · LLZ
Kostec Co., Ltd.
Radiology · 259d