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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 K193381
Device Name RadCalc Software
Applicant
LifeLine Software, Inc.
3304 S Broadway Ave, Suite 200
Tyler,  TX  75701
Applicant Contact Craig Laughton
Correspondent
LifeLine Software, Inc.
3304 S Broadway Ave, Suite 200
Tyler,  TX  75701
Correspondent Contact Craig Laughton
Regulation Number892.5050
Classification Product Code
MUJ  
Subsequent Product Code
IYE  
Date Received12/05/2019
Decision Date 12/31/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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