RayStation 11.0

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 11.0.

Pre-market Notification Details

Device IDK211867
510k NumberK211867
Device Name:RayStation 11.0
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant RaySearch Laboratories AB (publ) Sveavägen 44 Stockholm,  SE 111 34
ContactDavid Hedfors
CorrespondentDavid Hedfors
RaySearch Laboratories AB (publ) Sveavägen 44 Stockholm,  SE 111 34
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-16
Decision Date2021-09-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07350002010389 K211867 000

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