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
5569–5592 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 20, 2012
SYNGO.VIA
K123375 · LLZ
Siemens AG
Radiology · 19d
Cleared Nov 20, 2012
PHT-6500
K122606 · OAS
Mtechgroup
Radiology · 85d
Cleared Nov 20, 2012
FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION
K122454 · KPR
Fujifilm Medical System U.S.A., Inc.
Radiology · 99d
Cleared Nov 20, 2012
FUJIFILM TOMOSYNTHESIS OPTION FOR FDR ACSELERATE STATIONARY X-RAY SYSTEM
K121499 · IZF
Fujifilm Medical System U.S.A., Inc.
Radiology · 183d
Cleared Nov 16, 2012
CENTRICITY PACS-IW WITH UNIVERSAL VIEWER
K123174 · LLZ
Ge Healthcare
Radiology · 37d
Cleared Nov 16, 2012
VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY...
K122236 · JAQ
Varian Medical Systems, Inc.
Radiology · 113d
Cleared Nov 16, 2012
PEDIATRIC POSITIONER PAD SET
K122174 · KXH
Ge Healthcare Coils (Usa Instruments,...
Radiology · 116d
Cleared Nov 16, 2012
NEUVIZ 64 MULTI-SLICE CT SCANNER SYSTEM
K121792 · JAK
Neusoft Medical Systems Co., Ltd.
Radiology · 141d
Cleared Nov 16, 2012
STEREOS WORKSTATION
K113344 · LLZ
Eos Imaging
Radiology · 368d
Cleared Nov 13, 2012
OPTIMA MR 430S
K123068 · LNH
Ge Medical Systems, LLC
Radiology · 43d
Cleared Nov 05, 2012
SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO
K121434 · LNH
Siemens Medi Cal Solutions, Inc.
Radiology · 175d
Cleared Nov 02, 2012
DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM
K123185 · IYO
Shenzhen Mindray Bio-Medical...
Radiology · 23d
Cleared Nov 02, 2012
DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T
K122646 · MOS
Invivo Corporation
Radiology · 64d
Cleared Nov 02, 2012
VITREAADVANCED
K121213 · LLZ
Vital Images, Inc.
Radiology · 196d
Cleared Nov 02, 2012
FLIGHTPLAN FOR LIVER
K121200 · LLZ
Ge Healthcare
Radiology · 197d
Cleared Oct 26, 2012
ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM
K123001 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Oct 26, 2012
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY...
K122137 · IYE
Accuray Incorporated
Radiology · 100d
Cleared Oct 26, 2012
ECHONAVIGATOR RELEASE 1
K121781 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 130d
Cleared Oct 26, 2012
SUPERDIMENSION NITINOL/GOLD FIDUCIAL MARKER
K120796 · JAK
Superdimension, Inc.
Radiology · 225d
Cleared Oct 25, 2012
GE 8CH FOOT ANKLE COIL
K122694 · MOS
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 51d
Cleared Oct 24, 2012
IMAGE-COM 5.0
K122289 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 86d
Cleared Oct 24, 2012
IMAGEN3D
K122241 · KPS
Cardiovascular Imaging Technologies
Radiology · 89d
Cleared Oct 23, 2012
CARESTREAM VUE PACS
K122523 · LLZ
Carestream Health, Inc.
Radiology · 64d
Cleared Oct 23, 2012
PROTON RADIATION THERAPY BEAM-SHAPING APERTURE PROTON RADIAION THERAPY...
K121657 · IYE
Proton Systems
Radiology · 140d