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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 K864854
Device Name VIEW(TM) IMAGE PROCESSING AND VIEWING STATION
Applicant
Virtual Imaging
155 San Gabriel Dr.
Sunnyvale,  CA  94086
Applicant Contact ANDERSEN
Correspondent
Virtual Imaging
155 San Gabriel Dr.
Sunnyvale,  CA  94086
Correspondent Contact ANDERSEN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/11/1986
Decision Date 02/26/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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