AMALGA PACS


Device Classification Name

system, image processing, radiological

510(k) Number K023246
Device Name AMALGA PACS
Original Applicant
GLOBAL CARE SOLUTIONS, S.A.
2001 east oakshores dr.
crossroads, 
TX 
76227

Original Contact carl alletto
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 09/30/2002
Decision Date 12/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No