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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K083414
Device Name RADIONICS XKNIFE HDRT SYSTEM
Applicant
INTEGRA RADIONICS, INC.
22 TERRY AVENUE
BURLINGTON,  MA  01803
Applicant Contact KEVIN O'CONNELL
Correspondent
INTEGRA RADIONICS, INC.
22 TERRY AVENUE
BURLINGTON,  MA  01803
Correspondent Contact KEVIN O'CONNELL
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received11/18/2008
Decision Date 03/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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