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 Camera, Multi Format, Radiological
510(k) Number K083522
Device Name SONY UP-DF750 DIGITAL FILM IMAGER
Applicant
Sony Electronics, Inc.
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA SINCLAIR
Correspondent
Sony Electronics, Inc.
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA SINCLAIR
Regulation Number892.2040
Classification Product Code
LMC  
Date Received11/26/2008
Decision Date 01/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-