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, X-Ray, Angiographic
510(k) Number K133719
Device Name PDE-NEO
Applicant
Hamamatsu Photonics K.K.
700 13th St. NW Suite 1200
Washington Dc,  DC  20005
Applicant Contact JEFFREY K SHAPIRO
Correspondent
Hamamatsu Photonics K.K.
700 13th St. NW Suite 1200
Washington Dc,  DC  20005
Correspondent Contact JEFFREY K SHAPIRO
Regulation Number892.1600
Classification Product Code
IZI  
Subsequent Product Code
OWN  
Date Received12/05/2013
Decision Date 03/27/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
-
-