REGUIS SIGMA


Device Classification Name

solid state x-ray imager (flat panel/digital imager)

510(k) Number K103703
Device Name REGUIS SIGMA
Applicant
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
140 east 45th st., 25th floor
two grand central tower
new york, 
NY 
10017

Applicant Contact russell munves
Correspondent
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
140 east 45th st., 25th floor
two grand central tower
new york, 
NY 
10017

Correspodent Contact russell munves
Regulation Number 892.1680
Classification Product Code
MQB  
Date Received 12/20/2010
Decision Date 06/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No