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
5497–5520 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 22, 2013
SYNGO.VIA MI WORKFLOWS
K123577 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 63d
Cleared Jan 22, 2013
SYNAPSE 3D COLON ANALYSIS
K123566 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 63d
Cleared Jan 18, 2013
SYNGO.VIA
K123920 · LLZ
Siemens AG Medical Solutions
Radiology · 29d
Cleared Jan 18, 2013
PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
K123828 · IYN
Hitachi Aloka Medical, Ltd.
Radiology · 37d
Cleared Jan 18, 2013
XGEO GC80
K123098 · KPR
Samsung Electronics Co., Ltd.
Radiology · 108d
Cleared Jan 18, 2013
GENESIS
K122768 · JAA
Dornier Medtech America, Inc.
Radiology · 130d
Cleared Jan 18, 2013
CARDIAC VX
K121762 · LLZ
Ge Medical Systems, LLC
Radiology · 217d
Cleared Jan 17, 2013
BRIVO MR355, OPTIMA MR360
K123417 · LNH
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 72d
Cleared Jan 17, 2013
XOFT AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM MODEL 110
K122951 · JAD
Icad, Inc.
Radiology · 114d
Cleared Jan 17, 2013
ZEPHYR 'X-SERIES PATIENT TRANSFER SLED
K121929 · FRZ
Diacor, Inc.
Radiology · 199d
Cleared Jan 16, 2013
SYNGO DYNAMICS
K123922 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Jan 15, 2013
INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)
K123788 · IYE
Varian Medical Systems, Inc.
Radiology · 36d
Cleared Jan 15, 2013
ILAB ULTRASOUND IMAGING SYSTEM
K123535 · IYO
Boston Scientific Corp
Radiology · 60d
Cleared Jan 15, 2013
ERGO IMAGING SYSTEM
K123408 · IYX
Digirad Corp.
Radiology · 71d
Cleared Jan 14, 2013
VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING AND PRESSURE SYSTEM
K123898 · IYO
Volcano Corporation
Radiology · 27d
Cleared Jan 11, 2013
VIZION + DR
K123644 · MQB
Viztek, LLC
Radiology · 46d
Cleared Jan 11, 2013
SPECBOARD JR.
K123414 · IZH
Macbrud Corp., Medical Division
Radiology · 66d
Cleared Jan 11, 2013
1.5T GEM RT OPEN ARRAY
K123327 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 77d
Cleared Jan 11, 2013
IB CLINIC
K123302 · LLZ
Imaging Biometrics, LLC
Radiology · 80d
Cleared Jan 11, 2013
VIVIX-S WITH VXVUE
K122866 · MQB
Vieworks Co., Ltd.
Radiology · 115d
Cleared Jan 11, 2013
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
K122836 · IZH
Lorad, A Hologic Co.
Radiology · 116d
Cleared Jan 09, 2013
BEST LOCALIZATION NEEDLE WITH I-125 SEED
K122704 · KXK
Best Medical Intl.
Radiology · 127d
Cleared Jan 08, 2013
ALIGNRT PLUS
K123371 · IYE
Vision RT Limited
Radiology · 68d
Cleared Jan 07, 2013
VANTAGE MODEL V5000, V5100, V5000C, V5100C
K122643 · MUH
Midmark Corp.
Radiology · 131d