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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Simulation, Radiation Therapy
510(k) Number K914926
Device Name SCANDIPLAN - VERSION 338
Applicant
Scanditronix, Inc.
106 Western Ave.
Post Office Box 987
Essex,  MA  01929
Applicant Contact ROY EMANUELSON
Correspondent
Scanditronix, Inc.
106 Western Ave.
Post Office Box 987
Essex,  MA  01929
Correspondent Contact ROY EMANUELSON
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received11/04/1991
Decision Date 05/28/1992
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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