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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 K032248
Device Name PRECISE CARBON FIBER TABLE TOP, MODEL 11-999
Applicant
Aktina Medical Physics Corp.
360 N. Rte. 9w
Congers,  NY  10920
Applicant Contact TONY SPACCAROTELLA
Correspondent
Aktina Medical Physics Corp.
360 N. Rte. 9w
Congers,  NY  10920
Correspondent Contact TONY SPACCAROTELLA
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/22/2003
Decision Date 09/25/2003
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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