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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 K972211
Device Name MULTIDOS, QC6PLUS
Applicant
Ptw-New York Corp.
2437 Grand Ave.
Bellmore,  NY  11710
Applicant Contact STEPHEN R SZEGLIN
Correspondent
Ptw-New York Corp.
2437 Grand Ave.
Bellmore,  NY  11710
Correspondent Contact STEPHEN R SZEGLIN
Regulation Number892.5050
Classification Product Code
LHN  
Date Received06/12/1997
Decision Date 09/10/1997
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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