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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 K913755
Device Name STATVIEW
Applicant
Image Systems, Inc.
Consultant
16303 Panoramic Way
San Leandro,  CA  94578
Applicant Contact GARY J ALLSEBROOK
Correspondent
Image Systems, Inc.
Consultant
16303 Panoramic Way
San Leandro,  CA  94578
Correspondent Contact GARY J ALLSEBROOK
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/21/1991
Decision Date 11/19/1991
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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