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 K153312
Device Name SCATTER CORRECTION FOR CXDI SERIES
Applicant
CANON, INC
30-2 SHIMOMARUKO, 3-CHROME, OHTA-KU
TOKYO,  JP 146-8501
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 Received11/17/2015
Decision Date 06/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-