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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 K953482
Device Name XKNIFE-3
Applicant
Radionics Software Applications, Inc.
22 Terry Ave.
Burlington,  MA  01803
Applicant Contact LINDA JALBERT
Correspondent
Radionics Software Applications, Inc.
22 Terry Ave.
Burlington,  MA  01803
Correspondent Contact LINDA JALBERT
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/24/1995
Decision Date 10/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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