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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mammographic
510(k) Number K000976
Device Name DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)
Applicant
Instrumentarium Imaging, Inc.
300 W. Edgerton Ave.
Milwaukee,  WI  53207
Applicant Contact MAX LINDERT
Correspondent
Instrumentarium Imaging, Inc.
300 W. Edgerton Ave.
Milwaukee,  WI  53207
Correspondent Contact MAX LINDERT
Regulation Number892.1710
Classification Product Code
IZH  
Date Received03/27/2000
Decision Date 06/01/2000
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
Recalls CDRH Recalls
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