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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K963262
Device Name ARTOSCAN M
Applicant
Biosound, Inc.
8000 Castleway Dr.
Indianapolis,  IN  46250
Applicant Contact WAYNE NETHERCUTT
Correspondent
Biosound, Inc.
8000 Castleway Dr.
Indianapolis,  IN  46250
Correspondent Contact WAYNE NETHERCUTT
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/20/1996
Decision Date 03/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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