Ingenia Elition S and Ingenia Elition X
K-Number: K173451 · 2018-03-20
Decision Date2018-03-20
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Ingenia Elition S and Ingenia Elition X is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2018-03-20 under approval number K173451. 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 S and Ingenia Elition X?
Ingenia Elition S and Ingenia Elition X is a medical device that received FDA 510(k) clearance on 2018-03-20. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K173451.
When was Ingenia Elition S and Ingenia Elition X approved by the FDA?
Ingenia Elition S and Ingenia Elition X received FDA 510(k) clearance on 2018-03-20, under approval number K173451.
What company makes Ingenia Elition S and Ingenia Elition X?
Ingenia Elition S and Ingenia Elition X is manufactured by Philips Medical Systems Nederland B.V..
What is the FDA product code for Ingenia Elition S and Ingenia Elition X?
The FDA product code for Ingenia Elition S and Ingenia Elition X is LNH.
Other Devices by Philips Medical Systems Nederland B.V.
Related Devices (Code: LNH)
K162940MultiBand SENSEPhilips Medical Systems Nederland B.V.
K162183Vantage Galan 3T, MRT-3020, V4.0Toshibamedical Systems Corporation
K162102MAGNETOM Avantofit, MAGNETOM SkyrafitSiemens Medi Cal Solutions, Inc.
K162403HyperBandGe Medical Systems, LLC
K161795MAGNETOM ESSENZASiemens Medical Solutions USA, Inc.
K161973G-scan Brio, S-scanEsaote, S.p.A.
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.