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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
6865–6888 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 14, 2009
ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE
K083149 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 82d
Cleared Jan 14, 2009
LCD3090WQXI OR MD304MC 29.8 INCH DIAGNOSTIC IMAGING LCD MONITOR, MODEL L307TD
K083916 · LLZ
Nec Display Solutions , Ltd.
Radiology · 15d
Cleared Jan 13, 2009
SPECIALTY COILS FOR THE MAGNETOM ESSENZA
K083166 · MOS
Siemens Medical Solutions USA, Inc.
Radiology · 78d
Cleared Jan 13, 2009
FLYING DIAGNOSTIC ULTRASOUND SYSTEM
K083877 · ITX
Neusoft Medical Systems Co., Ltd.
Radiology · 15d
Cleared Jan 13, 2009
MD212MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR-L217TG
K083907 · LLZ
Nec Display Solutions , Ltd.
Radiology · 14d
Cleared Jan 09, 2009
IMAGESVR PACS
K082808 · LLZ
Jaguar Technology Limited
Radiology · 107d
Cleared Jan 09, 2009
ELLEX INNOVATIVE IMAGING EYE CUBED V4
K083061 · IYO
Ellex, Inc.
Radiology · 87d
Cleared Jan 09, 2009
MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK
K083332 · LLZ
Nec Display Solutions , Ltd.
Radiology · 58d
Cleared Jan 09, 2009
LUBRICANO-ULTRASOUND
K083358 · MUI
Farco Pharma GmbH
Radiology · 87d
Cleared Jan 09, 2009
SONY UP-DF750 DIGITAL FILM IMAGER
K083522 · LMC
Sony Electronics, Inc.
Radiology · 44d
Cleared Jan 08, 2009
WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER
K083274 · KXK
Biocompatibles, Inc.
Radiology · 63d
Cleared Jan 08, 2009
KUBTEC XPERT 20
K083510 · KPR
Kub Technologies, Inc.
Radiology · 43d
Cleared Jan 05, 2009
CARDIO VUE QUANTITATIVE ANALYSIS (CVQ)
K082526 · LLZ
Mri Cardiac Services, Incorporated
Radiology · 125d
Cleared Dec 30, 2008
CARESTREAM PACS, MODEL CARESTREAM PACS VII
K083673 · LLZ
Carestream Health, Inc.
Radiology · 19d
Cleared Dec 29, 2008
IKOENGELO, VERSION 2
K083591 · KPQ
Ikoetech, LLC
Radiology · 25d
Cleared Dec 23, 2008
RSVP HALF SPHERE PHANTOM, MODEL DDP010
K082909 · IYE
The Phantom Laboratory, Inc.
Radiology · 84d
Cleared Dec 23, 2008
HELIODENT PLUS
K083344 · EHD
Sirona Dental Systems GmbH
Radiology · 40d
Cleared Dec 23, 2008
IMAGE-ARENA APPLICATIONS
K083348 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 40d
Cleared Dec 23, 2008
TT1 GENERAL PURPOSE COIL
K083434 · MOS
Tursiop Technologies, LLC
Radiology · 33d
Cleared Dec 22, 2008
SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER
K081148 · IYO
Siemens Medical Solutions USA, Inc.,...
Radiology · 244d
Cleared Dec 19, 2008
CT BRAIN PERFUSION FOR ZIOSTATION
K083084 · LLZ
Ziosoft, Inc.
Radiology · 64d
Cleared Dec 19, 2008
ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM
K083254 · IYN
Aloka Co., Ltd.
Radiology · 45d
Cleared Dec 17, 2008
STASYS MOTION CORRECTION SOFTWARE
K082904 · KPS
Digirad Corp.
Radiology · 78d
Cleared Dec 17, 2008
PHILIPS MODEL MX 16 SLICE CT SYSTEM
K083498 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 22d