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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Charged-Particle, Medical
510(k) Number K981358
Device Name ARTOSCAN S
Applicant
Biosound Esaote, Inc.
8000 Castleway Dr.
Indianapolis,  IN  46250
Applicant Contact COLLEEN HITTLE
Correspondent
Biosound Esaote, Inc.
8000 Castleway Dr.
Indianapolis,  IN  46250
Correspondent Contact COLLEEN HITTLE
Regulation Number892.5050
Classification Product Code
LHN  
Date Received04/14/1998
Decision Date 07/13/1998
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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