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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,520 results
11329–11352 of 15,520
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 15, 1995
KODAK X-OMAT 5000 RA PROCESSOR
K951397 · IXW
Eastman Kodak Company
Radiology · 49d
Cleared May 12, 1995
DI-2000
K943602 · IYX
Miles Inc., Agfa Division
Radiology · 291d
Cleared May 12, 1995
MICRO MULTILEAF COLLIMATOR
K943714 · IYE
Leibinger F.L. Fischer
Radiology · 284d
Cleared May 12, 1995
MRH-1500
K943798 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 282d
Cleared May 12, 1995
PACS EQUIPMENT
K943994 · LMD
Rstar Image Management System
Radiology · 269d
Cleared May 12, 1995
IMWXDOP IR
K944196 · JAF
Imex Medical Systems, Inc.
Radiology · 256d
Cleared May 12, 1995
SIMULIX-HP
K946128 · KPQ
Oldelft Corp. of America
Radiology · 148d
Cleared May 12, 1995
MINI IMAGER
K950423 · LMC
Regulatory Management Services
Radiology · 99d
Cleared May 12, 1995
OPERAND* ULTRASOUND TRANSMISSION GEL
K951695 · IYN
Redi Products, Inc.
Radiology · 30d
Cleared May 11, 1995
PW DOPPLER VASCULAR PROBES
K935994 · ITX
Koven Technology, Inc.
Radiology · 512d
Cleared May 11, 1995
SHIMADZU IMAGE AMPLIFIER IA-12LM SERIES
K936236 · JAA
Shimadzu Medical Systems
Radiology · 497d
Cleared May 11, 1995
QCT-BONE MINERAL ANALYSIS SOFTWARE
K941127 · KGI
Image Analysis, Inc.
Radiology · 428d
Cleared May 11, 1995
REAL TIME STEREOTIX
K941191 · IZH
GE Medical Systems
Radiology · 423d
Cleared May 11, 1995
FUJI COMPUTED RADIOGRAPHY SYSTEMS
K944046 · IXW
Fujifilm Medical System U.S.A., Inc.
Radiology · 266d
Cleared May 11, 1995
ED CORP RADIATION SCREEN
K944445 · EAK
Med Corp.
Radiology · 241d
Cleared May 11, 1995
TETRAD MODEL BG22, AUTOMATIC BIOPSY UNIT MODEL
K945320 · ITX
Tetra Corp.
Radiology · 191d
Cleared May 11, 1995
R 302
K946320 · KPW
Ralco S.R.L.
Radiology · 134d
Cleared May 11, 1995
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
K950973 · LNH
GE Medical Systems
Radiology · 70d
Cleared May 11, 1995
FAST FIND GRID
K950980 · KPR
Webb Research, Inc.
Radiology · 69d
Cleared May 11, 1995
CATHETERIZATION TABLE KS-60
K951315 · IZZ
Shimadzu Medical Systems
Radiology · 49d
Cleared May 11, 1995
MED-TEC STRING RETICLE TRAY
K951601 · IWE
Medtec, Inc.
Radiology · 34d
Cleared May 11, 1995
SERIES 6600 DIGITAL MOBILE C-ARM
K951765 · OXO
Ge Dec Medical Systems
Radiology · 24d
Cleared May 10, 1995
JPI AUTOMATIC X-RAY FILM PROCESSOR
K950043 · IXW
Jpi Healthcare Co, Ltd.
Radiology · 125d
Cleared May 06, 1995
ARTHROGRAM TRAY
K950683 · JAA
Surgical Technologies, Inc.
Radiology · 81d