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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K950413
Device Name MEDIPACS
Applicant
NEXSYS ELECTRONICS
16303 PANORAMIC WAY
SAN LEANDRO,  CA  94578 -1116
Applicant Contact GARY J ALLSEBROOK
Correspondent
NEXSYS ELECTRONICS
16303 PANORAMIC WAY
SAN LEANDRO,  CA  94578 -1116
Correspondent Contact GARY J ALLSEBROOK
Regulation Number892.2020
Classification Product Code
LMD  
Date Received01/31/1995
Decision Date 06/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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