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 system, x-ray, extraoral source, digital
510(k) Number K122155
Device Name PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
Applicant
VATECH CO., LTD.
12946 KIMBERLEY LN
HOUSTON,  TX  77079
Applicant Contact DAVE KIM
Correspondent
VATECH CO., LTD.
12946 KIMBERLEY LN
HOUSTON,  TX  77079
Correspondent Contact DAVE KIM
Regulation Number872.1800
Classification Product Code
MUH  
Subsequent Product Code
MQB  
Date Received07/20/2012
Decision Date 09/04/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-