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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K042269
Device Name LEKSELL GAMMAPLAN 4C WITH MULTIVIEW
Applicant
Elekta Instrument AB
Kungstensgatan 18, P.O. Box 7593
Stockholm,  SE SE-103 93
Applicant Contact ANDERS SKOGLUND
Correspondent
Elekta Instrument AB
Kungstensgatan 18, P.O. Box 7593
Stockholm,  SE SE-103 93
Correspondent Contact ANDERS SKOGLUND
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received08/23/2004
Decision Date 09/08/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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