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
13489–13512 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 19, 1988
FAST AND CE-FAST MRI SEQUENCES (FOR NMR 1000)
K883519 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 62d
Cleared Oct 19, 1988
BETA 3000M MOBILE NMR IMAGING SYSTEM
K883648 · LNH
Fonar Corp.
Radiology · 50d
Cleared Oct 19, 1988
INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H
K883649 · LNH
Instrumentarium Corp.
Radiology · 51d
Cleared Oct 19, 1988
RADKOR SFR-70
K883864 · IYB
Radkor, Inc.
Radiology · 36d
Cleared Oct 19, 1988
RADKOR, RF-159
K883885 · KXJ
Radkor, Inc.
Radiology · 36d
Cleared Oct 13, 1988
BENNETT BCA-6 &BCA-9 MOBILE C-ARM UNIT/RADIO/FLOUR
K883092 · IZL
Bennett X-Ray Corp.
Radiology · 83d
Cleared Oct 13, 1988
VFQ HEAD COIL
K883737 · LNH
Resonex, Inc.
Radiology · 42d
Cleared Oct 12, 1988
DIGITRON STENOSIS PROTOCOL
K881481 · LLZ
Siemens Gammasonics, Inc.
Radiology · 187d
Cleared Oct 12, 1988
100-01778-52 ULTRASOUND SYSTEM
K882478 · IYO
Diasonics, Inc.
Radiology · 118d
Cleared Oct 11, 1988
P-7 COMPUTED TOMOGRAPHY SYSTEM
K882378 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 125d
Cleared Oct 11, 1988
SL SERIES ACCELERATORS SL15, SL18, SL20 & SL25
K883264 · IYE
Philips Medical Systems, Inc.
Radiology · 70d
Cleared Oct 07, 1988
DVS (OPTION 01)
K883101 · IYE
O.M.I. Oncology Microsystems, Inc.
Radiology · 77d
Cleared Oct 07, 1988
DIASONICS MT/P IMAGING SYSTEM
K883516 · LNH
Diasonics, Inc.
Radiology · 52d
Cleared Oct 07, 1988
0.5 T COMPACT MAGNET FOR ITS VISTA MR 2055 HP SYST
K883520 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 50d
Cleared Oct 07, 1988
TEEC (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) TRANSDUCER
K883546 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 49d
Cleared Oct 05, 1988
PROBE, IMAGING, ULTRASONIC, MECHANICAL SECTOR
K883965 · IYO
Teknar, Inc.
Radiology · 15d
Cleared Sep 30, 1988
MODIFIED SL-SERIES LINEAR ACCELERATORS
K883067 · IYE
Philips Medical Systems, Inc.
Radiology · 116d
Cleared Sep 29, 1988
HOLOGIC QDR-1000 X-RAY BONE DENSITOMETER/MODIFIED
K883280 · KGI
Hologic, Inc.
Radiology · 57d
Cleared Sep 27, 1988
HOLOGIC MODEL WHF-1 ANTHROPOMORPHIC FEMUR PHANTOM
K883360 · KGI
Hologic, Inc.
Radiology · 49d
Cleared Sep 22, 1988
SL SERIES, SL 15, 18, 20 & 25 (MODIFICATION)
K882231 · IYE
Philips Medical Systems, Inc.
Radiology · 118d
Cleared Sep 22, 1988
VISTA MR 2055 HP SYSTEM
K883378 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 44d
Cleared Sep 21, 1988
MEDACORD PVL, PERSONAL VASCULAR LABORATORY
K882018 · JAF
Medasonics, Inc.
Radiology · 131d
Cleared Sep 19, 1988
PXI (PERSONAL X-RAY IMAGER) 512
K881993 · LLZ
Oklahoma Digital Technologies, Inc.
Radiology · 130d
Cleared Sep 19, 1988
MAMMO M
K882133 · IZH
Ziehm International, Inc.
Radiology · 122d