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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 K192554
Device Name decimal3D
Applicant
.Decimal, LLC
121 Central Park Pl.
Sanford,  FL  32771
Applicant Contact Kevin Erhart
Correspondent
.Decimal, LLC
121 Central Park Pl.
Sanford,  FL  32771
Correspondent Contact Kevin Erhart
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received09/17/2019
Decision Date 12/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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