DX-D 100


Device Classification Name

system, x-ray, mobile

510(k) Number K103597
Device Name DX-D 100
Applicant
AGFA HEALTHCARE N.V.
10 s academy street
greenville, 
SC 
29601

Applicant Contact phil cuscuna
Regulation Number 892.1720
Classification Product Code
IZL  
Date Received 12/08/2010
Decision Date 01/03/2011
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