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 K213780
Device Name DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1
Applicant
Canon, Inc.
9-1 Imaikami-Cho Nakahara-Ku
Kawasaki,  JP 211-8501
Applicant Contact Akira Hirai
Correspondent
Ken Block Consulting
800 E. Campbell Dr., Suite 202
Richardson,  TX  75081
Correspondent Contact Gregory Woodard
Regulation Number892.1680
Classification Product Code
MQB  
Date Received12/02/2021
Decision Date 01/24/2022
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
-
-