RayStation 12A
K-Number: K222312 · 2023-03-29
ApplicantRaySearch Laboratories AB (PUBL)
Decision Date2023-03-29
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
RayStation 12A is a medical device manufactured by RaySearch Laboratories AB (PUBL). It received FDA 510(k) clearance on 2023-03-29 under approval number K222312. 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 12A?
RayStation 12A is a medical device that received FDA 510(k) clearance on 2023-03-29. It is manufactured by RaySearch Laboratories AB (PUBL). The 510(k) number is K222312.
When was RayStation 12A approved by the FDA?
RayStation 12A received FDA 510(k) clearance on 2023-03-29, under approval number K222312.
What company makes RayStation 12A?
RayStation 12A is manufactured by RaySearch Laboratories AB (PUBL).
What is the FDA product code for RayStation 12A?
The FDA product code for RayStation 12A 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.