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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 K000630
Device Name MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM
Applicant
Hopkins Imaging Systems, Inc.
1812 Flower St.
Duarte,  CA  91010
Applicant Contact RICHARD HOPKINS
Correspondent
Hopkins Imaging Systems, Inc.
1812 Flower St.
Duarte,  CA  91010
Correspondent Contact RICHARD HOPKINS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/24/2000
Decision Date 05/12/2000
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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