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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,668 results
11065–11088 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jul 25, 1996
ELITYS OR ELITYS-E
K962337 · EHD
Trophy Radiologie
Radiology · 38d
Cleared Jul 24, 1996
XRT 400
K955414 · KXJ
Wuestec Medical, Inc.
Radiology · 240d
Cleared Jul 24, 1996
MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300
K960083 · IXQ
Wuestec Medical, Inc.
Radiology · 195d
Cleared Jul 23, 1996
PRISM 3000XPV SYSTEM (210714)
K961577 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 90d
Cleared Jul 17, 1996
EUB-905
K962308 · IYO
Hitachi Medical Corp. of America
Radiology · 30d
Cleared Jul 09, 1996
FLEXART QD HEAD/NECK COIL
K961391 · MOS
Toshiba America Mri, Inc.
Radiology · 90d
Cleared Jul 05, 1996
FLEXIBLE PHASED ARRAY SPINE COIL
K960497 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 154d
Cleared Jul 05, 1996
DTX-200 BONE DENSITOMETER
K961011 · KGI
Shotwell & Carr, Inc.
Radiology · 114d
Cleared Jul 03, 1996
ADVANTAGE WINDOWS WITH FUNCTOOL OPTION
K960265 · LLZ
GE Medical Systems
Radiology · 167d
Cleared Jul 03, 1996
MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS
K961366 · LNH
Mri Devices Corp.
Radiology · 85d
Cleared Jul 03, 1996
MANAN PROSTATE LOCKING INTRODUCER SET
K961377 · IWJ
Manan Medical Products, Inc.
Radiology · 84d
Cleared Jul 03, 1996
LIFE IMAGING SYSTEMS LIS 6000 A
K961403 · LLZ
Life Imaging Systems, Inc.
Radiology · 83d
Cleared Jul 03, 1996
DICOMNET
K961451 · IZI
Lockheed Martin Communications Systems
Radiology · 78d
Cleared Jul 03, 1996
SELECT/SP
K961464 · JAK
Elscint, Inc.
Radiology · 77d
Cleared Jul 03, 1996
PICKER MR WORKSTATIONS (VISTAR,MONTAGE AND ONCALL)
K961637 · LLZ
Philips Medical Systems (Cleveland),...
Radiology · 65d
Cleared Jul 03, 1996
SONY DKR-700 DIGITAL STILL RECORDER
K961680 · LMB
Sony Medical Systems
Radiology · 63d
Cleared Jul 03, 1996
LUNAR REPORT GENERATOR
K961944 · KGI
Lunar Corp.
Radiology · 44d