RayStation 11.0
K-Number: K211867 · 2021-09-08
ApplicantRaySearch Laboratories AB (PUBL)
Decision Date2021-09-08
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
RayStation 11.0 is a medical device manufactured by RaySearch Laboratories AB (PUBL). It received FDA 510(k) clearance on 2021-09-08 under approval number K211867. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the RayStation 11.0?
RayStation 11.0 is a medical device that received FDA 510(k) clearance on 2021-09-08. It is manufactured by RaySearch Laboratories AB (PUBL). The 510(k) number is K211867.
When was RayStation 11.0 approved by the FDA?
RayStation 11.0 received FDA 510(k) clearance on 2021-09-08, under approval number K211867.
What company makes RayStation 11.0?
RayStation 11.0 is manufactured by RaySearch Laboratories AB (PUBL).
What is the FDA product code for RayStation 11.0?
The FDA product code for RayStation 11.0 is MUJ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.