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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 K903806
Device Name ANGIOTEC IMAGE MANAGEMENT SYSTEM
Applicant
Andros Analyzers, Inc.
2332 Fourth St.
Berkeley,  CA  94710
Applicant Contact RICHARD DALGETTY
Correspondent
Andros Analyzers, Inc.
2332 Fourth St.
Berkeley,  CA  94710
Correspondent Contact RICHARD DALGETTY
Regulation Number892.2010
Classification Product Code
LMB  
Date Received08/20/1990
Decision Date 11/23/1990
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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