Ingenia 1.5T and Ingenia 1.5T S R5.2
K-Number: K153324 · 2016-03-22
Decision Date2016-03-22
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Ingenia 1.5T and Ingenia 1.5T S R5.2 is a medical device manufactured by Philips Medical Systems Nederlands B.V.. It received FDA 510(k) clearance on 2016-03-22 under approval number K153324. 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 1.5T and Ingenia 1.5T S R5.2?
Ingenia 1.5T and Ingenia 1.5T S R5.2 is a medical device that received FDA 510(k) clearance on 2016-03-22. It is manufactured by Philips Medical Systems Nederlands B.V.. The 510(k) number is K153324.
When was Ingenia 1.5T and Ingenia 1.5T S R5.2 approved by the FDA?
Ingenia 1.5T and Ingenia 1.5T S R5.2 received FDA 510(k) clearance on 2016-03-22, under approval number K153324.
What company makes Ingenia 1.5T and Ingenia 1.5T S R5.2?
Ingenia 1.5T and Ingenia 1.5T S R5.2 is manufactured by Philips Medical Systems Nederlands B.V..
What is the FDA product code for Ingenia 1.5T and Ingenia 1.5T S R5.2?
The FDA product code for Ingenia 1.5T and Ingenia 1.5T S R5.2 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.