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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K052460
Device Name POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE
Applicant
RAMSOFT, INC.
16 FOUR SEASONS PLACE
SUITE 215
TORONTO,  CA M9B 6E5
Applicant Contact VIJAY RAMANATHAN
Correspondent
RAMSOFT, INC.
16 FOUR SEASONS PLACE
SUITE 215
TORONTO,  CA M9B 6E5
Correspondent Contact VIJAY RAMANATHAN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/07/2005
Decision Date 09/21/2005
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
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