FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
6841–6864 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Dec 16, 2008
NEURO III-SV
K083137 · LNH
Imris, Inc.
Radiology · 54d
Cleared Dec 16, 2008
PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION
K083555 · LLZ
Emsoma Co., Ltd.
Radiology · 14d
Cleared Dec 15, 2008
DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
K082224 · ITX
Shimadzu Medical Systems
Radiology · 131d
Cleared Dec 12, 2008
VISAGE PACS, VERSION 6.0/CS 3.1
K082269 · LLZ
Visage Imaging, Inc.
Radiology · 123d
Cleared Dec 12, 2008
IBA PROTON THERAPY SYSTEM- PROTEUS 235
K082416 · LHN
Ion Beam Applications S.A.
Radiology · 113d
Cleared Dec 12, 2008
MODEL TSX-301B AQUILION CT SYSTEM
K083282 · JAK
Toshiba America Medical Systems, In.C
Radiology · 35d
Cleared Dec 12, 2008
GE DISCOVERY NM/CT 570C
K083504 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 16d