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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 K844317
Device Name DMI CONSOLE
Applicant
Dimensional Medicine, Inc.
10901 Bren Rd. E.
Minnetonka,  MN  55343
Applicant Contact DALE B MOSER
Correspondent
Dimensional Medicine, Inc.
10901 Bren Rd. E.
Minnetonka,  MN  55343
Correspondent Contact DALE B MOSER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/06/1984
Decision Date 02/26/1985
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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