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 x-ray, tomography, computed, dental
510(k) Number K122606
Device Name PHT-6500; PHT-60CFO; PAX-I3D
Applicant
MTECH GROUP
12946 KIMBERLEY LN
HOUSTON,  TX  77079
Applicant Contact DAVE KIM
Correspondent
MTECH GROUP
12946 KIMBERLEY LN
HOUSTON,  TX  77079
Correspondent Contact DAVE KIM
Regulation Number892.1750
Classification Product Code
OAS  
Date Received08/27/2012
Decision Date 11/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-