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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K931410
Device Name NOVUS IMAGE ARCHIVE SYSTEM, TELERADIOLOGY SYSTEM
Applicant
Novus Technologies, Inc.
16303 Panoramic Way
San Leandro,  CA  94578
Applicant Contact GARY J ALLSEBROOK
Correspondent
Novus Technologies, Inc.
16303 Panoramic Way
San Leandro,  CA  94578
Correspondent Contact GARY J ALLSEBROOK
Regulation Number892.2010
Classification Product Code
LMB  
Date Received03/19/1993
Decision Date 02/18/1994
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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