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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 K070305
Device Name PRE-LOADED VISICOIL
Applicant
Radiomed Corporation
One Industrial Way
Tyngsboro,  MA  01879
Applicant Contact GORDON ROBERTS
Correspondent
Radiomed Corporation
One Industrial Way
Tyngsboro,  MA  01879
Correspondent Contact GORDON ROBERTS
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
JAK  
Date Received02/01/2007
Decision Date 03/07/2007
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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