FDA 510(k)

neo315

K-Number: K231133 · 2024-07-22

Decision Date2024-07-22

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

neo315 is a medical device manufactured by Neoscan Solution GmbH. It received FDA 510(k) clearance on 2024-07-22 under approval number K231133. 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 neo315?

neo315 is a medical device that received FDA 510(k) clearance on 2024-07-22. It is manufactured by Neoscan Solution GmbH. The 510(k) number is K231133.

When was neo315 approved by the FDA?

neo315 received FDA 510(k) clearance on 2024-07-22, under approval number K231133.

What company makes neo315?

neo315 is manufactured by Neoscan Solution GmbH.

What is the FDA product code for neo315?

The FDA product code for neo315 is LNH.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.