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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 K901422
Device Name SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF
Applicant
Image Systems, Inc.
Consultant
16303 Panoramic Way
San Leandro,  CA  94578
Applicant Contact J ALLSEBROOK
Correspondent
Image Systems, Inc.
Consultant
16303 Panoramic Way
San Leandro,  CA  94578
Correspondent Contact J ALLSEBROOK
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/26/1990
Decision Date 08/21/1990
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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