RayStation
K-Number: K190387 · 2019-06-19
ApplicantRaySearch Laboratories AB (PUBL)
Decision Date2019-06-19
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
RayStation is a medical device manufactured by RaySearch Laboratories AB (PUBL). It received FDA 510(k) clearance on 2019-06-19 under approval number K190387. 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?
RayStation is a medical device that received FDA 510(k) clearance on 2019-06-19. It is manufactured by RaySearch Laboratories AB (PUBL). The 510(k) number is K190387.
When was RayStation approved by the FDA?
RayStation received FDA 510(k) clearance on 2019-06-19, under approval number K190387.
What company makes RayStation?
RayStation is manufactured by RaySearch Laboratories AB (PUBL).
What is the FDA product code for RayStation?
The FDA product code for RayStation 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.