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 K160882
Device Name PaX-i3D Green Premium (Model: PCT-90LH)
Applicant
VATECH CO., LTD
13, SAMSUNG 1-RO 2-GIL
HWASEONG-SI,  KR 18449
Applicant Contact Daniel Kim
Correspondent
MTECH GROUP
8310 BUFFALO SPEEDWAY
HOUSTON,  TX  77025
Correspondent Contact Dave Kim
Regulation Number892.1750
Classification Product Code
OAS  
Date Received03/31/2016
Decision Date 10/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-