Ingenia Elition R5.7.1 SP4 MR Systems
K-Number: K232030 · 2023-08-02
Decision Date2023-08-02
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Ingenia Elition R5.7.1 SP4 MR Systems is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2023-08-02 under approval number K232030. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ingenia Elition R5.7.1 SP4 MR Systems?
Ingenia Elition R5.7.1 SP4 MR Systems is a medical device that received FDA 510(k) clearance on 2023-08-02. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K232030.
When was Ingenia Elition R5.7.1 SP4 MR Systems approved by the FDA?
Ingenia Elition R5.7.1 SP4 MR Systems received FDA 510(k) clearance on 2023-08-02, under approval number K232030.
What company makes Ingenia Elition R5.7.1 SP4 MR Systems?
Ingenia Elition R5.7.1 SP4 MR Systems is manufactured by Philips Medical Systems Nederland B.V..
What is the FDA product code for Ingenia Elition R5.7.1 SP4 MR Systems?
The FDA product code for Ingenia Elition R5.7.1 SP4 MR Systems is LNH.
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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.