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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 K141561
Device Name VM PACS WITH VM MEDICAL WORKSTATION
Applicant
VISUAL MEDICA
ecuador 1465 1 d
ciudad autonoma de buenos aires,  AR cp 1425
Applicant Contact melissa llabres grau
Correspondent
VISUAL MEDICA
ecuador 1465 1 d
ciudad autonoma de buenos aires,  AR cp 1425
Correspondent Contact melissa llabres grau
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/12/2014
Decision Date 01/16/2015
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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