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
7801–7824 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 19, 2006
ABARIS
K053610 · JAK
Traxtal Technologies, Inc.
Radiology · 113d
Cleared Apr 19, 2006
GE LIGHTSPEED XTRA CT SCANNER SYSTEM
K060052 · JAK
Ge Medical Systems, LLC
Radiology · 103d
Cleared Apr 19, 2006
PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE
K060636 · KXK
C.R. Bard, Inc.
Radiology · 40d
Cleared Apr 19, 2006
PROBEAT WITH MGCS
K060834 · LHN
Hitachi , Ltd.
Radiology · 23d
Cleared Apr 19, 2006
MODEL EC9-4 TRANSDUCER
K060879 · ITX
Siemens Medical Solutions USA, Inc.
Radiology · 19d
Cleared Apr 19, 2006
MODIFICATION TO: HI-ART SYSTEM
K060912 · IYE
Tomotherapy Incorporated
Radiology · 16d
Cleared Apr 19, 2006
CAAS MRV VERSION 3.0
K060941 · LLZ
Pie Medical Imaging BV
Radiology · 13d
Cleared Apr 19, 2006
SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020
K060947 · ITX
Boston Scientific Corp
Radiology · 13d
Cleared Apr 14, 2006
VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE...
K060873 · MOS
Sentinelle Medical, Inc.
Radiology · 15d
Cleared Apr 14, 2006
GALILEOS
K060892 · MUH
Sirona Dental Systems GmbH
Radiology · 11d
Cleared Apr 11, 2006
HDR 1000 PLUS WELL CHAMBER, MODEL 90008
K060532 · JAQ
Standard Imaging, Inc.
Radiology · 42d
Cleared Apr 11, 2006
VUMAX
K060626 · IYO
Sonomed, Inc.
Radiology · 33d
Cleared Apr 11, 2006
IBA PROTON THERAPY SYSTEM - PROTEUS 235
K060695 · LHN
Ion Beam Applications S.A.
Radiology · 26d
Cleared Apr 10, 2006
STETHOFLUX
K060064 · JAF
Odvi
Radiology · 91d
Cleared Apr 10, 2006
ECHOHEART TRANSVAGINAL DOPPLER PROBE
K060410 · HEK
Summit Doppler Systems, Inc.
Radiology · 53d
Cleared Apr 07, 2006
SEEKER/SPARK ULTRASOUND SYSTEM
K060800 · IYO
Ardent Sound, Inc.
Radiology · 14d
Cleared Apr 07, 2006
SVIEW
K060840 · LLZ
Mri Cardiac Services, Incorporated
Radiology · 10d
Cleared Apr 06, 2006
ROTATING GAMMA SYSTEM. GAMMA ART-6000
K060314 · IWB
American Radiosurgery, Inc.
Radiology · 57d
Cleared Apr 05, 2006
MINXRAY, MODELS HFP24 AND HFP40
K060566 · IZL
Mikasa X-Ray Co., Ltd.
Radiology · 33d
Cleared Apr 05, 2006
ADVANCE VESSEL ANALYSIS II
K060779 · JAK
Ge Healthcare
Radiology · 14d
Cleared Apr 04, 2006
XPERCT
K060749 · IZI
Philips Medical Systems North America...
Radiology · 15d
Cleared Apr 03, 2006
DOSE VERIFICATION SYSTEM
K052118 · LHN
Sicel Technologies, Inc.
Radiology · 242d
Cleared Mar 31, 2006
MAXILIM
K052424 · LLZ
Medicim NV
Radiology · 210d
Cleared Mar 31, 2006
GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX
K060542 · IYN
General Electric Co.
Radiology · 30d