Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name system, image processing, radiological
510(k) Number K130336
Device Name 5MP MONOCHROME LCD MONITOR, RADIFORCE GX540
Applicant
EIZO NANAO CORPORATION
153 SHIMOKASHIWANO, HAKUSAN
ISHIKAWA,  JP 924-8566
Applicant Contact HIROAKI HASHIMOTO
Correspondent
EIZO NANAO CORPORATION
153 SHIMOKASHIWANO, HAKUSAN
ISHIKAWA,  JP 924-8566
Correspondent Contact HIROAKI HASHIMOTO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/11/2013
Decision Date 03/28/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-