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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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