DX-D 600


Device Classification Name

system, x-ray, stationary

510(k) Number K112670
Device Name DX-D 600
Applicant
AGFA HEALTHCARE N.V.
10 s academy street
greenville, 
SC 
29601

Applicant Contact phil cuscuna
Regulation Number 892.1680
Classification Product Code
KPR  
Date Received 09/14/2011
Decision Date 10/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls