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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 K012289
Device Name MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID)
Applicant
Elekta Oncology Systems, Ltd.
3155 Northwoods Pkwy.
Norcross,  GA  30071
Applicant Contact PETER STEGAGNO
Correspondent
Elekta Oncology Systems, Ltd.
3155 Northwoods Pkwy.
Norcross,  GA  30071
Correspondent Contact PETER STEGAGNO
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/20/2001
Decision Date 08/14/2001
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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