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
10825–10848 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 16, 1997
EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS
K964307 · KGI
Lunar Corp.
Radiology · 169d
Cleared Apr 16, 1997
PIXI BONE DENSITOMETER
K970224 · KGI
Lunar Corp.
Radiology · 85d
Cleared Apr 16, 1997
STATNET
K970525 · IZI
Gorca Systems, Inc.
Radiology · 64d
Cleared Apr 15, 1997
EXL-12SP,12DP,15DP,20DP LINAC
K970137 · IYE
Mitsubishi Electronics America, Inc.
Radiology · 90d
Cleared Apr 11, 1997
ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA)
K970128 · KPS
Park Medical Systems, Inc.
Radiology · 87d
Cleared Apr 07, 1997
DOWNSCAN 120
K970451 · LLZ
Merlin Engineering Works, Inc.
Radiology · 60d
Cleared Apr 04, 1997
KODAK EKTASIAN HG FILM (EHG-15)
K970154 · IWZ
Eastman Kodak Company
Radiology · 78d
Cleared Apr 04, 1997
IMEX FUTURALDOP PRO
K970156 · IYO
Imex Medical Systems, Inc.
Radiology · 78d
Cleared Apr 04, 1997
PICTURE ARCHIVING & COMMUNICATIONS DEVICE
K970534 · LLZ
Multimedia Solutions
Radiology · 51d
Cleared Apr 04, 1997
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K970606 · JAK
GE Medical Systems
Radiology · 45d
Cleared Apr 03, 1997
CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM
K962627 · LNI
Siemens Medical Solutions USA, Inc.
Radiology · 272d
Cleared Apr 03, 1997
ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM
K963616 · IYN
Aloka Co., Ltd.
Radiology · 205d
Cleared Apr 01, 1997
LINAC SCALPEL FLOORSTAND
K964517 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 140d
Cleared Apr 01, 1997
UPSCAN 120
K970450 · LLZ
Merlin Engineering Works, Inc.
Radiology · 54d
Cleared Apr 01, 1997
PROSTYLE INTRA
K970975 · EHD
Planmeca Oy
Radiology · 15d
Cleared Mar 31, 1997
ACCESSPOINT, MED E-MAIL, DICOM READER
K963936 · LMB
Biosound, Inc.
Radiology · 181d
Cleared Mar 31, 1997
E. CAM PROFILE ATTENUATION CORRECTION
K963983 · KPS
Siemens Corp.
Radiology · 178d
Cleared Mar 31, 1997
FUJI MEDICAL LASER IMAGER MF PRINT SERVER MF-PS667
K970349 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 60d
Cleared Mar 28, 1997
BIO-BINKI
K961782 · JAA
Biomni Medical Systems, Inc.
Radiology · 324d
Cleared Mar 28, 1997
ARTOSCAN M
K963262 · LNH
Biosound, Inc.
Radiology · 220d
Cleared Mar 28, 1997
GYREX 2T-PRESTIGE
K970005 · LNI
Elscint, Inc.
Radiology · 85d
Cleared Mar 26, 1997
LEVEL 10 HDI
K961459 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 344d
Cleared Mar 26, 1997
DOCTORS REVIEW SYSTEM
K970402 · LLZ
Digisonics, Inc.
Radiology · 51d
Cleared Mar 21, 1997
EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS
K962010 · LLZ
Philips Medical Systems (Cleveland),...
Radiology · 302d