IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)

Device Classification Name

system, image processing, radiological

510(k) Number K071297
Device Name IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)
Applicant
AGFA HEALTHCARE CORP.
10 south academy st.
greenville, 
SC 
29601

Applicant Contact tom holbrook
Correspondent
AGFA HEALTHCARE CORP.
10 south academy st.
greenville, 
SC 
29601

Correspodent Contact tom holbrook
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 05/09/2007
Decision Date 06/22/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls