NEWTOM 5G / NEWTOM 5G VERSION FP


Device Classification Name

x-ray, tomography, computed, dental

510(k) Number K110260
Device Name NEWTOM 5G / NEWTOM 5G VERSION FP
Applicant
QR S.R.L.
via silvestrini 20
verona, vr, 

IT

37135

Applicant Contact lorenzo bortolotti
Correspondent
QR S.R.L.
via silvestrini 20
verona, vr, 

IT

37135

Correspodent Contact lorenzo bortolotti
Regulation Number 892.1750
Classification Product Code
OAS  
Date Received 01/28/2011
Decision Date 04/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No