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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 K923522
Device Name LINAC-BASED STEROTACTIC RADIOSURGERY
Applicant
Radionics Software Applications, Inc.
2 Brookline Pl.
Suite 204
Brookline,  MA  02146
Applicant Contact LINDA JALBERT
Correspondent
Radionics Software Applications, Inc.
2 Brookline Pl.
Suite 204
Brookline,  MA  02146
Correspondent Contact LINDA JALBERT
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/16/1992
Decision Date 08/18/1993
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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