Ingenia 1.5T CX and Ingenia 3.0T CX R5.3
K-Number: K162931 · 2017-01-06
Decision Date2017-01-06
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2017-01-06 under approval number K162931. 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 CX and Ingenia 3.0T CX R5.3?
Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 is a medical device that received FDA 510(k) clearance on 2017-01-06. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K162931.
When was Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 approved by the FDA?
Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 received FDA 510(k) clearance on 2017-01-06, under approval number K162931.
What company makes Ingenia 1.5T CX and Ingenia 3.0T CX R5.3?
Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 is manufactured by Philips Medical Systems Nederland B.V..
What is the FDA product code for Ingenia 1.5T CX and Ingenia 3.0T CX R5.3?
The FDA product code for Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 is LNH.
Other Devices by Philips Medical Systems Nederland B.V.
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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.