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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 K981641
Device Name MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ
Applicant
Instrumentarium Corp.
300 W. Edgerton Ave.
Milwaukee,  WI  53207
Applicant Contact MAX LINDERT
Correspondent
Instrumentarium Corp.
300 W. Edgerton Ave.
Milwaukee,  WI  53207
Correspondent Contact MAX LINDERT
Regulation Number892.1710
Classification Product Code
IZH  
Date Received05/08/1998
Decision Date 07/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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