FDA 510(k)

HyperSense

K-Number: K162722 · 2017-04-20

Decision Date2017-04-20

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

HyperSense is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2017-04-20 under approval number K162722. 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 HyperSense?

HyperSense is a medical device that received FDA 510(k) clearance on 2017-04-20. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K162722.

When was HyperSense approved by the FDA?

HyperSense received FDA 510(k) clearance on 2017-04-20, under approval number K162722.

What company makes HyperSense?

HyperSense is manufactured by Ge Medical Systems, LLC.

What is the FDA product code for HyperSense?

The FDA product code for HyperSense is LNH.

Other Devices by Ge Medical Systems, LLC

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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.