FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,433 results
11545–11568 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 23, 1994
HISPEED ADVANTAGE II
K940606 · JAK
GE Medical Systems
Radiology · 194d
Cleared Aug 23, 1994
ACCESS
K940796 · LNH
Toshiba America Mri, Inc.
Radiology · 182d
Cleared Aug 23, 1994
IMEXDOP CT+
K942441 · JAF
Imex Medical Systems, Inc.
Radiology · 92d
Cleared Aug 22, 1994
DIAGNOSTIC INSTRUMLENTS INC. MODEL T803 BREAST COIL
K934318 · LNH
Diagnostic Instrument Corp.
Radiology · 355d
Cleared Aug 22, 1994
UROVIEW MODEL 2600
K940295 · JAA
Ge Dec Medical Systems
Radiology · 213d
Cleared Aug 22, 1994
VASCULAR MP X-RAY GENERATOR
K943652 · IZO
GE Medical Systems
Radiology · 25d
Cleared Aug 22, 1994
KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC
K943821 · EAM
Fujifilm Medical System U.S.A., Inc.
Radiology · 68d
Cleared Aug 22, 1994
FUJI UM MAMMO SERIES INTENSIFY SCREENS:
K943822 · EAM
Fujifilm Medical System U.S.A., Inc.
Radiology · 68d
Cleared Aug 22, 1994
FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12
K943823 · EAM
Fujifilm Medical System U.S.A., Inc.
Radiology · 68d
Cleared Aug 17, 1994
CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT
K933320 · IYO
Cardio Metrics, Inc.
Radiology · 406d
Cleared Aug 17, 1994
RADWORKS
K934645 · EAP
Radworks Corp.
Radiology · 330d
Cleared Aug 17, 1994
KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP
K940386 · IXL
Eastman Kodak Company
Radiology · 203d
Cleared Aug 17, 1994
COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH
K940550 · IWJ
Cook, Inc.
Radiology · 191d
Cleared Aug 17, 1994
VIDEO PLUS WITH ANALYTICAL WORKSTATION
K941979 · IZI
Camtronics, Ltd.
Radiology · 114d
Cleared Aug 17, 1994
LINEAR TOMOGRAPHIC SYSTEM: PMT 6000
K942175 · IZF
Continental X-Ray Corp.
Radiology · 105d
Cleared Aug 17, 1994
ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE
K942190 · IXQ
Image Diagnostics, Inc.
Radiology · 105d
Cleared Aug 17, 1994
KYOKKO GREEN SERIES INTENSIFYING SCREENS
K942235 · EAM
Fujifilm Medical System U.S.A., Inc.
Radiology · 100d
Cleared Aug 17, 1994
FUJI HG-M INTENSIFYING SCREEN
K943425 · EAM
Fujifilm Medical System U.S.A., Inc.
Radiology · 33d
Cleared Aug 17, 1994
RSX-525HF
K943504 · IZO
Fischer Imaging Corp.
Radiology · 28d
Cleared Aug 12, 1994
SLICES
K941812 · LNH
Microsignal Corp.
Radiology · 122d
Cleared Aug 09, 1994
VARIAN C/D-SERIES CLINACS (CLINAC 600 C/D)
K926321 · IYE
Varian Assoc., Inc.
Radiology · 601d
Cleared Aug 09, 1994
RFA A-300
K934303 · IYE
Scanditronix, Inc.
Radiology · 342d
Cleared Aug 09, 1994
ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES
K935157 · KPX
Regulatory Consultants TO the Medical...
Radiology · 285d
Cleared Aug 09, 1994
OEC 901
K942841 · JAA
Baldwin
Radiology · 54d