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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 K150547
Device Name .decimal Astroid Dosimetry App
Applicant
.decimal, inc
121 Central Park Place
Sanford,  FL  32771
Applicant Contact KEVIN ERHART
Correspondent
.decimal, inc
121 Central Park Place
Sanford,  FL  32771
Correspondent Contact KEVIN ERHART
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received03/03/2015
Decision Date 05/15/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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