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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 K991546
Device Name AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD
Applicant
Aktina Medical Physics Corp.
360 N. Rte. 9w
Congers,  NY  10920
Applicant Contact JOAN ZACHAROPOULOS
Correspondent
Aktina Medical Physics Corp.
360 N. Rte. 9w
Congers,  NY  10920
Correspondent Contact JOAN ZACHAROPOULOS
Regulation Number892.5050
Classification Product Code
IYE  
Date Received05/03/1999
Decision Date 07/30/1999
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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