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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 K931022
Device Name ARTOSCAN
Applicant
Biosound, Inc.
7990 Castleway Dr.
P.O. Box 50867
Indianapolis,  IN  46250
Applicant Contact WAYNE NETHERCUTT
Correspondent
Biosound, Inc.
7990 Castleway Dr.
P.O. Box 50867
Indianapolis,  IN  46250
Correspondent Contact WAYNE NETHERCUTT
Regulation Number892.1000
Classification Product Code
LNH  
Date Received03/01/1993
Decision Date 10/07/1993
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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