PAX-FLEX3D, PHT-7000


Device Classification Name

x-ray, tomography, computed, dental

510(k) Number K121412
Device Name PAX-FLEX3D, PHT-7000
Applicant
VATECH CO., LTD.
12946 kimberley ln
houston, 
TX 
77079

Applicant Contact dave kim
Correspondent
VATECH CO., LTD.
12946 kimberley ln
houston, 
TX 
77079

Correspodent Contact dave kim
Regulation Number 892.1750
Classification Product Code
OAS  
Date Received 05/11/2012
Decision Date 06/08/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No