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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K900434
Device Name MM-22 MICROTRON, MM50 MICROTRON
Applicant
Scanditronix, Inc.
106 Western Ave.
Post Office Box 987
Essex,  MA  01929
Applicant Contact ROY M EMANUELSON
Correspondent
Scanditronix, Inc.
106 Western Ave.
Post Office Box 987
Essex,  MA  01929
Correspondent Contact ROY M EMANUELSON
Regulation Number892.5050
Classification Product Code
IYE  
Date Received01/30/1990
Decision Date 10/23/1990
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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