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
12769–12792 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 19, 1991
MODEL 3150-21 QUADRATURE SPINE COIL IN POSITIONER
K910514 · LNH
Medical Advances, Inc.
Radiology · 42d
Cleared Mar 18, 1991
DOSE CALIBRATOR
K905796 · KPT
Capintec Instruments, Inc.
Radiology · 81d
Cleared Mar 15, 1991
HELICAL SCAN
K910375 · JAK
Toshiba America Medical Systems, In.C
Radiology · 45d
Cleared Mar 15, 1991
7.5 MHZ PEDIATRIC TRANSESOPHAGEAL ECHO (TEE) TRANS
K910529 · ITX
Siemens Ultrasound, Inc.
Radiology · 35d
Cleared Mar 15, 1991
5 MHZ ADULT/PEDI TRANSESOPHAGEAL ECHO(TEE) TRANSDU
K910669 · ITX
Siemens Ultrasound, Inc.
Radiology · 28d
Cleared Mar 12, 1991
KODAK X-OMAT MULTILOADER 300
K905607 · IXW
Eastman Kodak Company
Radiology · 88d
Cleared Mar 08, 1991
PHILIPS GYROVIEW-HR IMAGING WORKSTATION
K905603 · LNH
Philips Medical Systems, Inc.
Radiology · 85d
Cleared Mar 07, 1991
SENSI RADS LEAD LATEX RADIATION PROT. GLOVE, STER.
K904878 · IWP
Hpi, Inc.
Radiology · 128d
Cleared Mar 07, 1991
ANTERIOR NECK CONTOUR COIL
K905512 · LNH
Magnetic Research, Inc.
Radiology · 87d
Cleared Mar 07, 1991
MAMEX DC AMI SL12/MG15
K905748 · IZH
Soredex, Inc.
Radiology · 71d
Cleared Mar 07, 1991
VPW 2877E6 X-RAY POWER SUPPLY
K910820 · IZO
Varian Canada, Inc.
Radiology · 10d
Cleared Mar 06, 1991
MICRO-X 80HF
K905695 · IZO
Fischer Imaging Corp.
Radiology · 77d
Cleared Mar 06, 1991
X-RAY TUBE HOUSING ASSEMBLY SOREDEX DC/CIR 51
K910276 · ITY
Inmark Corp.
Radiology · 42d
Cleared Mar 06, 1991
DI2000/HS-45-150 X-RAY TUBE INSERT
K910842 · ITY
Comet Ltd. C/O Radiology Resources, Inc.
Radiology · 7d
Cleared Mar 05, 1991
QUICK-CLIP NEEDLE GUIDE
K903561 · ITX
Acuson Corp.
Radiology · 210d
Cleared Mar 05, 1991
ESI-3000 ULTRASOUND SYSTEM
K904359 · IYN
Elscint, Inc.
Radiology · 162d
Cleared Mar 04, 1991
COMPACT LASER IMAGER, MODEL CLI-100
K902347 · LMC
Lumisys, Inc.
Radiology · 283d
Cleared Feb 28, 1991
ALOKA UST-952DP-5 ENDOVAGINAL TRANSDUCER
K905535 · ITX
Ge Medical Systems Information...
Radiology · 80d
Cleared Feb 27, 1991
VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C
K904364 · IYE
Varian Assoc., Inc.
Radiology · 156d
Cleared Feb 26, 1991
ULTRAMARK 9 ULTRASOUND SYSTEM (UM 9)
K903603 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 202d
Cleared Feb 26, 1991
HFQ SERIES CONTROLS AND GENERATORS
K905799 · IZO
Bennett X-Ray Corp.
Radiology · 88d
Cleared Feb 25, 1991
EUB-315
K905294 · IYO
Hitachi Medical Corp. of America
Radiology · 90d
Cleared Feb 25, 1991
MRP -5000(1): VERSION 2.0 SOFTWARE
K905832 · LNH
Summit World Trade Corp.
Radiology · 56d
Cleared Feb 25, 1991
MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY
K905833 · LNH
Summit World Trade Corp.
Radiology · 56d