NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM


Device Classification Name

system,x-ray,extraoral source,digital

510(k) Number K072357
Device Name NEWTOM VG COMPUTED TOMOGRAPHY X-RAY SYSTEM
Applicant
AFP IMAGING CORP.
49 plain st.
north attleboro, 
MA 
02760

Applicant Contact mary mcnamara-cullinane
Correspondent
AFP IMAGING CORP.
49 plain st.
north attleboro, 
MA 
02760

Correspodent Contact mary mcnamara-cullinane
Regulation Number 872.1800
Classification Product Code
MUH  
Date Received 08/22/2007
Decision Date 09/18/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No