PHT-6500; PHT-60CFO; PAX-I3D


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

Correspodent Contact dave kim
Regulation Number 892.1750
Classification Product Code
OAS  
Date Received 08/27/2012
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