Astroid Planning App

System, Planning, Radiation Therapy Treatment

.decimal, LLC.

The following data is part of a premarket notification filed by .decimal, Llc. with the FDA for Astroid Planning App.

Pre-market Notification Details

Device IDK173940
510k NumberK173940
Device Name:Astroid Planning App
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant .decimal, LLC. 121 Central Park Place Sanford,  FL  32771
ContactKevin Erhart
CorrespondentKevin Erhart
.decimal, LLC. 121 Central Park Place Sanford,  FL  32771
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-26
Decision Date2018-05-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851147007120 K173940 000

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