INTELLISPACE PACS 4.X


Device Classification Name

system, image processing, radiological

510(k) Number K111804
Device Name INTELLISPACE PACS 4.X
Applicant
PHILIPS HEALTHCARE INFORMATICS, INC.
4100 e 3rd ave ste 101
foster city, 
CA 
94404

Applicant Contact victoria s mackinnon
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 06/27/2011
Decision Date 07/28/2011
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