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
11209–11232 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 21, 1996
SIENET TELERADIOLOGY PRODUCT LINE
K955394 · LMC
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Feb 13, 1996
SHIMASONIC SDU-350 ELECTRONIC LINEAR/CONVEX DIAGNOSTIC ULTRASOUND SYSTEM
K953634 · IYO
Shimadzu Medical Systems
Radiology · 195d
Cleared Feb 12, 1996
OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)
K952892 · ITX
Olympus America, Inc.
Radiology · 234d
Cleared Feb 12, 1996
ULTRASOUND PROBE BIOPSY ACCESSORIES
K955458 · ITX
Biosound, Inc.
Radiology · 75d
Cleared Feb 12, 1996
JPI AUTOMATIC X-RAY FILM PROCESSOR
K955706 · IXW
Jpi Healthcare Co, Ltd.
Radiology · 59d
Cleared Feb 09, 1996
ULTRASOUND SCANNER 2002
K943315 · IYO
B&K Medical
Radiology · 578d
Cleared Feb 09, 1996
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TX
K955255 · JAK
Shimadzu Medical Systems
Radiology · 88d
Cleared Feb 06, 1996
BIOCCLUS 4
K960104 · EJT
Degussa Corp.
Radiology · 26d
Cleared Feb 02, 1996
VARIAN MULTILEAF COLLIMATOR
K943224 · IYE
Varian Assoc., Inc.
Radiology · 577d
Cleared Feb 02, 1996
TEE PROBE
K953579 · ITX
Biosound, Inc.
Radiology · 185d
Cleared Feb 02, 1996
JPI INTENSIFYING SCREEN
K954161 · EAM
Jpi Healthcare Co, Ltd.
Radiology · 150d
Cleared Feb 02, 1996
HIGH TRANSMISSION CELLULAR (HTC) GRIDS 18X24 CM & 24X30 CM SIZES
K954294 · IXJ
Thermotrex Corp.
Radiology · 141d
Cleared Jan 30, 1996
PQ-2000+ COMPUTED TOMOGRAPHY X-RAY SYSTEM
K955268 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 74d
Cleared Jan 29, 1996
HANEL MAVIG MONITOR SUSPENSION SYSTEM
K954945 · JAA
F. Walter Hanel GmbH
Radiology · 91d
Cleared Jan 29, 1996
LILY DARK VIEWER
K954998 · IXC
Lily Imaging Solutions Co.
Radiology · 89d
Cleared Jan 26, 1996
SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE
K953250 · IZH
GE Medical Systems
Radiology · 198d
Cleared Jan 26, 1996
REMOTE VIEWING SYSTEM MEDICAL IMAGE DISPLAY MODULE
K955000 · LMD
Cerner Corp.
Radiology · 86d
Cleared Jan 26, 1996
SHIMADZU WHOLE BODY X-RAY SCANNER SCT-7000TH
K955253 · JAK
Shimadzu Medical Systems
Radiology · 74d
Cleared Jan 26, 1996
SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TC
K955254 · JAK
Shimadzu Medical Systems
Radiology · 74d
Cleared Jan 24, 1996
ACCULUPE
K955184 · LMB
E For M Imaging Systems Div.,...
Radiology · 72d
Cleared Jan 18, 1996
TRANSMISSION ATTENUATION CORRECTION (TAC) PACKAGE
K952190 · KPS
Sopha Medical Systems, Inc.
Radiology · 254d
Cleared Jan 18, 1996
SCANMASTER DX
K953117 · LMA
Howtek, Inc.
Radiology · 199d
Cleared Jan 18, 1996
EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS
K954646 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 100d
Cleared Jan 17, 1996
EXL-12SP & 12DP LINAC
K952314 · IYE
Mitsubishi Intl. Corp.
Radiology · 245d