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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 K042794
Device Name BEAM MODULATOR, MODEL 4513 332 8000
Applicant
Elekta , Ltd.
4775 Peachtree Industrial Blvd.
Bldg. 300, Suite 300
Norcross,  GA  30092
Applicant Contact PETER STEGAGNO
Correspondent
Elekta , Ltd.
4775 Peachtree Industrial Blvd.
Bldg. 300, Suite 300
Norcross,  GA  30092
Correspondent Contact PETER STEGAGNO
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
IXI  
Date Received10/07/2004
Decision Date 01/31/2005
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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