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
5641–5664 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 29, 2012
TOMOTHERAPY TREATMENT SYSTEM
K121934 · IYE
Accuray Incorporated
Radiology · 58d
Cleared Aug 28, 2012
PAX-UNI3D, PHT-7500
K121400 · OAS
VATECH Co., Ltd.
Radiology · 110d
Cleared Aug 28, 2012
FDR GO FLEX
K120629 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 180d
Cleared Aug 28, 2012
KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY...
K120246 · MUE
Carestream Health, Inc.
Radiology · 214d
Cleared Aug 28, 2012
AIXPLORER
K112255 · IYN
Supersonic Imagine
Radiology · 389d
Cleared Aug 24, 2012
AIXPLORER
K121329 · IYN
Supersonic Imagine
Radiology · 114d
Cleared Aug 22, 2012
SYSTEM, X-RAY, STATIONARY
K121854 · KPR
Beijing Sinopharm Hundric Mediline...
Radiology · 58d
Cleared Aug 21, 2012
VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM
K121063 · IYN
Ge Medical System Israel , Ltd.
Radiology · 137d
Cleared Aug 17, 2012
OCTAVE SPEEDER SPINE
K121911 · MOS
Toshiba Medical Systems Corporation,...
Radiology · 49d
Cleared Aug 17, 2012
OCTAVE SPEEDER HEAD
K121910 · MOS
Toshiba Medical Systems Corporation,...
Radiology · 49d
Cleared Aug 17, 2012
VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEM
K121062 · ITX
Ge Medical System Israel , Ltd.
Radiology · 133d
Cleared Aug 17, 2012
LUNG VOLUME ANALYSIS
K113715 · JAK
Toshibamedical Systems Corporation
Radiology · 242d
Cleared Aug 16, 2012
BIOJET
K122329 · LLZ
Jet Soft Srl
Radiology · 15d
Cleared Aug 16, 2012
OEC 9900 ELITE
K122234 · OWB
Ge Healthcare Surgery GE Oec Medical...
Radiology · 21d
Cleared Aug 16, 2012
DIGITAL FLAT PANEL X-RAY DETECTOR/1717SGC
K122182 · MQB
Rayence Co., Ltd.
Radiology · 24d
Cleared Aug 16, 2012
APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM
K121422 · IYO
Toshiba Medical Systems Coporation,...
Radiology · 94d
Cleared Aug 16, 2012
DX-D IMAGING PACKAGE
K121095 · MQB
Agfa Healthcare N.V.
Radiology · 127d
Cleared Aug 15, 2012
EXINI
K122205 · LLZ
Exini Diagnostics AB
Radiology · 21d
Cleared Aug 14, 2012
EXACTRAC X-RAY X-RAY
K120789 · IYE
Brainlab AG
Radiology · 152d
Cleared Aug 13, 2012
FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2
K120446 · FDS
Fujinon, Inc.
Radiology · 181d
Cleared Aug 10, 2012
IMRIS ONCOLOGY PACKAGE
K121997 · LNH
Imris, Inc.
Radiology · 32d
Cleared Aug 10, 2012
MULTIX FUSION
K121513 · KPR
Siemens Medical Solution
Radiology · 81d
Cleared Aug 10, 2012
BIOPSY DIGIT S BIOPSY SL
K113607 · IZH
Giotto USA, LLC
Radiology · 248d
Cleared Aug 10, 2012
ADVANTAGE-STRAND/ADVANTAGE-LOAD BRACHYTHERAPY KIT
K113210 · KXK
Isoaid, LLC
Radiology · 283d