REGISTRATION AND FUSION


Device Classification Name

system, image processing, radiological

510(k) Number K080013
Device Name REGISTRATION AND FUSION
Applicant
AGFA HEALTHCARE CORPORATION
10 south academy street
greenville, 
SC 
29601

Applicant Contact tom holbrook
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 01/03/2008
Decision Date 01/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No