RayStation 7
K-Number: K180379 · 2018-04-25
ApplicantRaySearch Laboratories AB (PUBL)
Decision Date2018-04-25
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
RayStation 7 is a medical device manufactured by RaySearch Laboratories AB (PUBL). It received FDA 510(k) clearance on 2018-04-25 under approval number K180379. 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 7?
RayStation 7 is a medical device that received FDA 510(k) clearance on 2018-04-25. It is manufactured by RaySearch Laboratories AB (PUBL). The 510(k) number is K180379.
When was RayStation 7 approved by the FDA?
RayStation 7 received FDA 510(k) clearance on 2018-04-25, under approval number K180379.
What company makes RayStation 7?
RayStation 7 is manufactured by RaySearch Laboratories AB (PUBL).
What is the FDA product code for RayStation 7?
The FDA product code for RayStation 7 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.