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
10561–10584 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Oct 08, 1997
ROTOGRAPH PLUS
K972968 · EHD
Chicago X-Ray Systems, Inc.
Radiology · 58d
Cleared Oct 08, 1997
DRTS IMAGE INTENSIFIER DRAPE
K973073 · JAA
Minrad, Inc.
Radiology · 51d
Cleared Oct 08, 1997
MAMMOLOADER BY C.M.A. SRL
K973125 · IXW
C.M.A.
Radiology · 49d
Cleared Oct 08, 1997
AMBER DU
K973219 · KPR
Oldelft Corp. of America
Radiology · 42d
Cleared Oct 08, 1997
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH
K973327 · JAK
Shimadzu Medical Systems
Radiology · 34d
Cleared Oct 08, 1997
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX
K973329 · JAK
Shimadzu Medical Systems
Radiology · 34d
Cleared Oct 08, 1997
DAR-3000B
K973342 · IZI
Shimadzu Corp.
Radiology · 33d