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
10081–10104 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 10, 1999
`INEAR WRIST COIL, MODEL 440GE-09
K991113 · MOS
Medical Advances, Inc.
Radiology · 70d
Cleared Jun 09, 1999
INTERSOURCE 125, MODEL 1251L
K984235 · KXK
International Brachytherapy, Inc.
Radiology · 196d
Cleared Jun 09, 1999
SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION
K991600 · JAK
Siemens Corp.
Radiology · 30d
Cleared Jun 09, 1999
GE LOGIQ 500
K991611 · IYO
General Electric Co.
Radiology · 30d
Cleared Jun 08, 1999
RPM RESPIRATORY GATING SYSTEM
K983629 · LHN
Varian Medical Systems, Inc.
Radiology · 236d
Cleared Jun 08, 1999
VIVOSONIC
K984562 · ITX
Sonotech, Inc.
Radiology · 167d
Cleared Jun 08, 1999
DOSE CALC, MODEL VS. 1.02
K990833 · IYE
Integrity Medical Software, Inc.
Radiology · 88d
Cleared Jun 08, 1999
LINEAR SHOULDER COIL, MODEL 414GE-09
K991115 · MOS
Medical Advances, Inc.
Radiology · 68d
Cleared Jun 08, 1999
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS W/FLUORO OPTION
K991553 · JAK
Shimadzu Corp.
Radiology · 36d
Cleared Jun 08, 1999
IDS4 V3.2 IMAGE DISPLAY SYSTEM
K991643 · LLZ
O Tech, Inc.
Radiology · 26d
Cleared Jun 03, 1999
SMARTSPOT 2000
K991578 · LLZ
Cmt Medical Technologies, Ltd.
Radiology · 28d
Cleared Jun 03, 1999
SSA-370A/POWERVISION 6000
K991710 · IYO
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Jun 02, 1999
GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER,...
K991236 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 51d
Cleared Jun 01, 1999
SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS
K991302 · IXC
Smartlight, Inc.
Radiology · 46d
Cleared May 28, 1999
DPD-12PCC
K990734 · IYE
Scanditronix Medical AB
Radiology · 84d
Cleared May 27, 1999
GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER
K990753 · JAQ
Cook, Inc.
Radiology · 80d
Cleared May 27, 1999
E-SCAN
K990968 · LNH
Biosound Esaote, Inc.
Radiology · 65d
Cleared May 24, 1999
HITACHI VERSIFLEX
K991231 · IZI
Hitachi Medical Systems America, Inc.
Radiology · 42d
Cleared May 21, 1999
LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001
K984328 · IWB
Elekta Instrument AB
Radiology · 169d
Cleared May 20, 1999
IODINE BRACHYTHERAPY SEEDS, MODEL 3000
K990193 · KXK
Implant Sciences Corp.
Radiology · 119d
Cleared May 20, 1999
LIFE IMAGING SYSTEMS, MODEL L3DI
K990560 · IYO
Life Imaging Systems, Inc.
Radiology · 87d
Cleared May 20, 1999
EXTRA LARGE BODY COIL FOR OPART (MRT-600)
K991057 · MOS
Toshiba America Mri, Inc.
Radiology · 51d
Cleared May 20, 1999
AII-PRO 100 PLUS AND ALL-PRO 200
K991435 · IXW
All-Pro Imaging Corp.
Radiology · 24d
Cleared May 19, 1999
OSTEOGRAM BONE DENSITOMETER
K984285 · KGI
Compumed, Inc.
Radiology · 169d