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
10705–10728 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 21, 1997
AXT 150M MANUAL COLLIMATOR (AXT 150M)
K972966 · IZX
Applied X-Ray Technologies, Inc.
Radiology · 10d
Cleared Aug 20, 1997
ASSET APOLLO
K971884 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 90d
Cleared Aug 20, 1997
KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM
K971894 · LMA
Eastman Kodak Company
Radiology · 90d
Cleared Aug 15, 1997
VARIAN RADIATION THERAPY IMAGING SYSTEM
K971839 · KPQ
Varian Medical Systems, Inc.
Radiology · 88d
Cleared Aug 15, 1997
TDK MEDICAL GRADE CD-R
K971848 · LMB
Tdk Electronics Corporation of America
Radiology · 88d
Cleared Aug 15, 1997
DEVMED STEPPING AND STABILIZING SYSTEM
K972152 · ITX
Devmed Corp.
Radiology · 67d
Cleared Aug 15, 1997
ALOKA SSD-1400 DIAGNOSTIC ULTRASOUND SYSTEM
K972465 · IYN
Aloka Co., Ltd.
Radiology · 45d
Cleared Aug 14, 1997
PIVOTING COMPENSATING FILTERS FOR THE HEAD
K972766 · KPR
Octostop, Inc.
Radiology · 21d
Cleared Aug 08, 1997
VANTAGE 2.1 EXSPECT
K971878 · KPS
Adac Laboratories
Radiology · 79d
Cleared Aug 08, 1997
PIXI YOUNG ADULT REFERENC POPULATION FOR OS CALCIS AND FOREARM
K972053 · KGI
Lunar Corp.
Radiology · 67d
Cleared Aug 06, 1997
COLORFLO OPTION FOR THE ORACLE INVISION INTRAVASCULAR ULTRASONIC IMAGING SYSTEM
K963290 · IYO
Endosonics Corp.
Radiology · 350d
Cleared Aug 05, 1997
ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING
K963451 · IYE
Topslane
Radiology · 336d
Cleared Aug 05, 1997
PM 2002 CC PROLINE
K970812 · EHD
Planmeca Oy
Radiology · 153d
Cleared Aug 05, 1997
MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)
K971684 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Aug 04, 1997
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM
K970508 · IYO
Shimadzu Medical Systems
Radiology · 175d
Cleared Jul 30, 1997
INTRACAVITY NEEDLE GUIDE KIT
K955668 · ITX
Arlanda Medicinska Instrument Co. AB
Radiology · 595d
Cleared Jul 29, 1997
GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM
K964886 · IYN
GE Medical Systems
Radiology · 235d
Cleared Jul 29, 1997
VELOS CONSTANCY CHECK DEVICE, MODEL 55-145
K970384 · IYE
Aktina Medical Physics Corp.
Radiology · 176d
Cleared Jul 29, 1997
THE MIDVIEW-MEDCON'S DICOM VIEWER
K971181 · IZI
Medcon , Ltd.
Radiology · 120d
Cleared Jul 29, 1997
BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND...
K972672 · ITX
Barzell-Whitmore Maroon Bells, Inc.
Radiology · 13d
Cleared Jul 25, 1997
OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND...
K971660 · FDS
Olympus America, Inc.
Radiology · 80d
Cleared Jul 24, 1997
SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS
K971668 · LNH
GE Medical Systems
Radiology · 79d
Cleared Jul 24, 1997
HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM
K972348 · ITX
Hewlett-Packard Co.
Radiology · 30d
Cleared Jul 23, 1997
TARGET 2 VERSION 1.1
K965010 · IYE
GE Medical Systems
Radiology · 219d