RayStation 11B
K-Number: K220141 · 2022-04-15
ApplicantRaySearch Laboratories AB (PUBL)
Decision Date2022-04-15
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
RayStation 11B is a medical device manufactured by RaySearch Laboratories AB (PUBL). It received FDA 510(k) clearance on 2022-04-15 under approval number K220141. 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 11B?
RayStation 11B is a medical device that received FDA 510(k) clearance on 2022-04-15. It is manufactured by RaySearch Laboratories AB (PUBL). The 510(k) number is K220141.
When was RayStation 11B approved by the FDA?
RayStation 11B received FDA 510(k) clearance on 2022-04-15, under approval number K220141.
What company makes RayStation 11B?
RayStation 11B is manufactured by RaySearch Laboratories AB (PUBL).
What is the FDA product code for RayStation 11B?
The FDA product code for RayStation 11B 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.