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
10633–10656 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 04, 1997
IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS
K972903 · JAK
Imatron, Inc.
Radiology · 90d
Cleared Oct 31, 1997
APOLLO
K972882 · KGI
Norland Corp.
Radiology · 87d
Cleared Oct 28, 1997
NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE-...
K972271 · KXK
Ml Strategies, Inc.
Radiology · 132d
Cleared Oct 28, 1997
XPLAN-1
K972905 · IYE
Radionics Software Applications, Inc.
Radiology · 83d
Cleared Oct 28, 1997
HELIOS LASER IMAGER 1417
K973028 · LMC
Sterling Diagnostic Imaging, Inc.
Radiology · 75d
Cleared Oct 28, 1997
MEDSTATION
K973090 · LMD
Program S.R.L.
Radiology · 71d
Cleared Oct 28, 1997
LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT])
K973422 · LMC
Dejarnette Research Systems
Radiology · 48d
Cleared Oct 27, 1997
BRAINSCAN CONFORMAL RT MODULE
K971367 · IYE
Brainlab AG
Radiology · 196d
Cleared Oct 27, 1997
VOX/BASE FOR WINDOWS
K972933 · LLZ
J-Mac System, Inc.
Radiology · 80d
Cleared Oct 23, 1997
MCD-AC
K971980 · KPS
Adac Laboratories
Radiology · 147d
Cleared Oct 23, 1997
BANG POLYMER GEL DOSIMETER, BANG 533
K972804 · IYE
Mgs Research, Inc.
Radiology · 87d
Cleared Oct 17, 1997
STRAIT'MAP OPTION
K973368 · IZI
Ge Medical Systems, Inc.
Radiology · 39d
Cleared Oct 16, 1997
IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM
K972229 · IZI
Heartware, Inc.
Radiology · 125d
Cleared Oct 16, 1997
TBI STAND
K972709 · IYE
Mick Radio-Nuclear Instruments, Inc.
Radiology · 87d
Cleared Oct 16, 1997
LEGACY/LEGACY-D TABLE
K973039 · IXR
GE Medical Systems
Radiology · 63d
Cleared Oct 16, 1997
DRTS REMOTE CONTROL DRAPE
K973067 · JAA
Minrad, Inc.
Radiology · 59d
Cleared Oct 15, 1997
ESTEEM 1.5T MRI SYSTEM
K972826 · LNH
Elscint Mr, Inc.
Radiology · 78d
Cleared Oct 15, 1997
ULTRAFAST CT SCANNER
K972879 · JAK
Imatron, Inc.
Radiology · 71d
Cleared Oct 15, 1997
PERCEPTION INC. GPS-TUV DIAGNOSTIC ULTRASOUND SYSTEM
K972973 · IYO
Perception, Inc.
Radiology · 65d
Cleared Oct 14, 1997
VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER
K972686 · KPS
Smv America
Radiology · 89d
Cleared Oct 09, 1997
DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED:...
K972130 · IZJ
Fairmontmedical
Radiology · 125d
Cleared Oct 08, 1997
MD100 & MM150
K963913 · EAM
Konica Medical Corp.
Radiology · 373d
Cleared Oct 08, 1997
CM & CM DS-7
K963914 · IXA
Konica Medical Corp.
Radiology · 373d
Cleared Oct 08, 1997
ACU-RAY HF SERIES PORTABLE X-RAY UNIT
K972204 · IZL
Sterne Equipment Co., Ltd.
Radiology · 118d