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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 K912630
Device Name XKNIFE RADIOSURGERY SYSTEM
Applicant
Rsa, Inc.
2 Brookline Pl.
Suite 205
Brookline,  MA  02146
Applicant Contact ROBERT J LEDOUX
Correspondent
Rsa, Inc.
2 Brookline Pl.
Suite 205
Brookline,  MA  02146
Correspondent Contact ROBERT J LEDOUX
Regulation Number892.5050
Classification Product Code
IYE  
Date Received06/17/1991
Decision Date 11/04/1991
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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