FXA (TM)


Device Classification Name

system, image processing, radiological

510(k) Number K110765
Device Name FXA (TM)
Applicant
ACES GMBH
ludwigstr. 26
filderstadt, bw, 

DE

70794

Applicant Contact frank t trautwein
Correspondent
ACES GMBH
ludwigstr. 26
filderstadt, bw, 

DE

70794

Correspodent Contact frank t trautwein
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 03/18/2011
Decision Date 11/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No