• 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 K170332
Device Name DIGITAL RADIOGRAPHY CXDI-710C WIRELESS, DIGITAL RADIOGRAPHY CXDI-810C WIRELESS
Applicant
Canon, Inc.
9-1, Imaikami-Cho
NAKAHARA-ku, KAWASAKI,  JP 211-8501
Applicant Contact SHINJI MORI
Correspondent
Ken Block Consulting
1201 Richardson Drive, Suite 160
Richardson,  TX  75080
Correspondent Contact DIANE RUTHERFORD
Regulation Number892.1680
Classification Product Code
MQB  
Date Received02/02/2017
Decision Date 03/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-