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
10969–10992 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 13, 1996
TRS 2000 TELERADIOLOGY SYSTEM
K961983 · LLZ
Sectra-Imtec AB
Radiology · 85d
Cleared Aug 09, 1996
HEAD RETAINING DEVICE
K961467 · IYE
S. and H. Engineering, Inc.
Radiology · 116d
Cleared Aug 08, 1996
HP SONOS ULTRASOUND IMAGING SYSTEM
K954028 · IYN
Hewlett-Packard Co.
Radiology · 346d
Cleared Aug 08, 1996
MENTOR ADVENT A/B SYSTEM
K960765 · IYO
Mentor Ophthalmics, Inc.
Radiology · 164d
Cleared Aug 08, 1996
FIRST BEAT/CARDIO BEAT/CALC
K961116 · IYO
Medasonics, Inc.
Radiology · 141d
Cleared Aug 08, 1996
SIEMENS BEAM SHAPER
K961902 · IXI
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Aug 07, 1996
TOPOGRAPHIC IMAGING MARKER
K962606 · JAA
I.Z.I. Medical Products Corp.
Radiology · 36d
Cleared Aug 06, 1996
MULTI LEAF COLLIMATOR
K961214 · IYE
Mitsubishi Intl. Corp.
Radiology · 131d
Cleared Aug 05, 1996
BRAINLAB CT/X-RAY LOCALIZER
K954861 · IYE
Brainlab Med. Computersysteme GmbH
Radiology · 287d
Cleared Aug 02, 1996
ULTRAMAX/MODEL NUMBER A1
K960044 · LWI
Entlab OY
Radiology · 213d
Cleared Aug 02, 1996
SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM
K961842 · LNH
Toshiba America Mri, Inc.
Radiology · 81d
Cleared Aug 01, 1996
MRTOFLM COMPUTER PROGRAM
K960293 · IYE
Northwest Medical Physics Equipment,...
Radiology · 198d
Cleared Jul 31, 1996
INFINET
K961689 · LMD
Infimed, Inc.
Radiology · 91d
Cleared Jul 31, 1996
FLOUROSPOT T.O.P.
K961871 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 77d
Cleared Jul 26, 1996
ECHO. AKHO
K951976 · IYO
Alliance Medical, Inc.
Radiology · 456d
Cleared Jul 26, 1996
APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER
K955844 · JAQ
Varian Assoc., Inc.
Radiology · 213d
Cleared Jul 25, 1996
EXPERT SPINE MORPHOTIETRY REFERENCE
K961007 · KGI
Lunar Corp.
Radiology · 135d
Cleared Jul 25, 1996
KILTEX PROBE COVER
K961029 · IYO
Kiltex Corp.
Radiology · 133d
Cleared Jul 25, 1996
KODAK MN-R 2000 CASSETTE
K961453 · IXA
Eastman Kodak Company
Radiology · 100d
Cleared Jul 25, 1996
SHARED VISION(PART NUMBER SV 0015)
K961753 · LMD
Imagelabs, Inc.
Radiology · 80d
Cleared Jul 25, 1996
ECOGEL 100 ULTRASOUND GEL
K961757 · ITX
Eco-Med Pharmaceuticals, Inc.
Radiology · 80d
Cleared Jul 25, 1996
AIRIS
K961876 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 71d
Cleared Jul 25, 1996
TOMOGRAPH ACCESSORIES
K962120 · EHD
Steri-Oss, Inc.
Radiology · 55d
Cleared Jul 25, 1996
ICT-2000, INTEGRATED C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC...
K962140 · JAA
Continental X-Ray Corp.
Radiology · 52d