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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 K161341
Device Name LIFESYS PACS
Applicant
LIFETRACK MEDICAL SYSTEMS, INC.
1007 ONE WORLD PLACE, 32ND STREET, BGC
taguig city,  PH 1634
Applicant Contact eric schulze
Correspondent
FISH & RICHARDSON
1425 K STREET NW
washington,  DC  20005
Correspondent Contact keith barritt
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/13/2016
Decision Date 04/05/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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