RayCare 2.3
K-Number: K191384 · 2019-07-08
ApplicantRaySearch Laboratories AB (PUBL)
Decision Date2019-07-08
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
RayCare 2.3 is a medical device manufactured by RaySearch Laboratories AB (PUBL). It received FDA 510(k) clearance on 2019-07-08 under approval number K191384. 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 2.3?
RayCare 2.3 is a medical device that received FDA 510(k) clearance on 2019-07-08. It is manufactured by RaySearch Laboratories AB (PUBL). The 510(k) number is K191384.
When was RayCare 2.3 approved by the FDA?
RayCare 2.3 received FDA 510(k) clearance on 2019-07-08, under approval number K191384.
What company makes RayCare 2.3?
RayCare 2.3 is manufactured by RaySearch Laboratories AB (PUBL).
What is the FDA product code for RayCare 2.3?
The FDA product code for RayCare 2.3 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.