RayStation

System, Planning, Radiation Therapy Treatment

RaySearch Laboratories AB (publ)

The following data is part of a premarket notification filed by Raysearch Laboratories Ab (publ) with the FDA for Raystation.

Pre-market Notification Details

Device IDK200569
510k NumberK200569
Device Name:RayStation
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant RaySearch Laboratories AB (publ) Sveavägen 44 Stockholm,  SE 11134
ContactViktoria Hammarstedt
CorrespondentViktoria Hammarstedt
RaySearch Laboratories AB (publ) Sveavägen 44 Stockholm,  SE 11134
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-04
Decision Date2020-09-24

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