IMPAX NEXT GENERATION


Device Classification Name

system, image processing, radiological

510(k) Number K111945
Device Name IMPAX NEXT GENERATION
Applicant
AGFA HEALTHCARE N.V.
septestraat 27
mortsel, 

BE

b 2640

Applicant Contact jodi coleman
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 07/08/2011
Decision Date 08/05/2011
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