RayStation 11B

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 11b.

Pre-market Notification Details

Device IDK220141
510k NumberK220141
Device Name:RayStation 11B
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant RaySearch Laboratories AB (publ) Eugeniavägen 18 Stockholm,  SE 113 68
ContactDavid Hedfors
CorrespondentDavid Hedfors
RaySearch Laboratories AB (publ) Eugeniavägen 18 Stockholm,  SE 113 68
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-18
Decision Date2022-04-15

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.