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 Changer, Radiographic Film/Cassette
510(k) Number K851067
Device Name CANON X-RAY FILM CHANGER CFC-U1
Applicant
Canon USA, Inc.
One Canon Plaza
Lake Success,  NY  11042 -1198
Applicant Contact TAMADA
Correspondent
Canon USA, Inc.
One Canon Plaza
Lake Success,  NY  11042 -1198
Correspondent Contact TAMADA
Regulation Number892.1860
Classification Product Code
KPX  
Date Received03/18/1985
Decision Date 05/21/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-