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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 K914698
Device Name SETUP COMPUTER WITH SOFTWARE V-1261,62 AND 63
Applicant
K.S., Inc.
1926 Elm Tree Dr.
Nashville,  TN  37210
Applicant Contact VIVIAN DENTON
Correspondent
K.S., Inc.
1926 Elm Tree Dr.
Nashville,  TN  37210
Correspondent Contact VIVIAN DENTON
Regulation Number892.5050
Classification Product Code
IYE  
Date Received10/18/1991
Decision Date 06/05/1992
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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