DDRELEMENT


Device Classification Name

system, x-ray, stationary

510(k) Number K110828
Device Name DDRELEMENT
Applicant
SWISSRAY MEDICAL AG
one tower center
east brunswick, 
NJ 
07201

Applicant Contact john monahan
Correspondent
SWISSRAY MEDICAL AG
one tower center
east brunswick, 
NJ 
07201

Correspodent Contact john monahan
Regulation Number 892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received 03/24/2011
Decision Date 08/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No