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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,488 results
9937–9960 of 15,488
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 22, 1999
MODIFICATION TO DIGIPAN
K991912 · EHD
Trophy Radiologie
Radiology · 15d
Cleared Jun 18, 1999
KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR
K990969 · IXW
Konica Medical Corp.
Radiology · 87d
Cleared Jun 18, 1999
NORMA 10
K991243 · LNH
Odin Technologies , Ltd.
Radiology · 67d
Cleared Jun 18, 1999
EXPLOR-X 70
K991310 · EHD
Villa Sistemi Medicali S.P.A.
Radiology · 63d
Cleared Jun 18, 1999
CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
K991318 · KPS
Hitachi Medical Corp. of America
Radiology · 60d
Cleared Jun 18, 1999
PANATOME
K991518 · EHD
Imaging Sciences Intl., Inc.
Radiology · 49d
Cleared Jun 18, 1999
HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
K991671 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 32d
Cleared Jun 18, 1999
HISPEED NX/I CT SCANNER SYSTEM
K991716 · JAK
Ge Medical Systems, Inc.
Radiology · 29d
Cleared Jun 17, 1999
ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501
K991526 · KXK
Imagyn Medical Technologies, Inc.
Radiology · 45d
Cleared Jun 16, 1999
SSA-390A/POWER VISION 8000
K991858 · IYN
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Jun 16, 1999
LYNX ULTRASOUND SYSTEM
K991872 · IYN
Ecton, Inc.
Radiology · 15d
Cleared Jun 11, 1999
SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGING
K991842 · IYO
Ge Vingmed Ultrasound
Radiology · 14d
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