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 solid state x-ray imager (flat panel/digital imager)
510(k) Number K023586
Device Name DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS
Applicant
CANON U.S.A., INC.
ONE CANON PLAZA
LAKE SUCCESS,  NY  11042 -1198
Applicant Contact SHIELA DRISCOLL
Correspondent
CANON U.S.A., INC.
ONE CANON PLAZA
LAKE SUCCESS,  NY  11042 -1198
Correspondent Contact SHIELA DRISCOLL
Regulation Number892.1680
Classification Product Code
MQB  
Date Received10/25/2002
Decision Date 11/05/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-