RayCare (2024A SP1)
K-Number: K242992 · 2025-04-17
ApplicantRaySearch Laboratories AB (PUBL)
Decision Date2025-04-17
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
RayCare (2024A SP1) is a medical device manufactured by RaySearch Laboratories AB (PUBL). It received FDA 510(k) clearance on 2025-04-17 under approval number K242992. 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 RayCare (2024A SP1)?
RayCare (2024A SP1) is a medical device that received FDA 510(k) clearance on 2025-04-17. It is manufactured by RaySearch Laboratories AB (PUBL). The 510(k) number is K242992.
When was RayCare (2024A SP1) approved by the FDA?
RayCare (2024A SP1) received FDA 510(k) clearance on 2025-04-17, under approval number K242992.
What company makes RayCare (2024A SP1)?
RayCare (2024A SP1) is manufactured by RaySearch Laboratories AB (PUBL).
What is the FDA product code for RayCare (2024A SP1)?
The FDA product code for RayCare (2024A SP1) 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.