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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 K010464
Device Name RADCALC, MODEL V.4.0
Applicant
Lifeline Software, Inc.
403 Mockingbird Ln.
Tyler,  TX  75701 -3053
Applicant Contact CRAIG A LAUGHTON
Correspondent
Lifeline Software, Inc.
403 Mockingbird Ln.
Tyler,  TX  75701 -3053
Correspondent Contact CRAIG A LAUGHTON
Regulation Number892.5050
Classification Product Code
IYE  
Date Received02/16/2001
Decision Date 05/17/2001
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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