REGIUS UNITEA

Device Classification Name

system, image processing, radiological

510(k) Number K071436
Device Name REGIUS UNITEA
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 892.2050
Classification Product Code
LLZ  
Date Received 05/23/2007
Decision Date 06/27/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No