FDA 510(k)

Motion Correction System

K-Number: K193324 · 2020-02-04

Decision Date2020-02-04

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Motion Correction System is the device name listed in this FDA 510(k) record. The listed applicant is Kineticor, Inc.. It received FDA 510(k) clearance on 2020-02-04 under 510(k) number K193324. 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 Motion Correction System?

Motion Correction System is a medical device that received FDA 510(k) clearance on 2020-02-04. The listed applicant is Kineticor, Inc.. The 510(k) number is K193324.

When did Motion Correction System receive FDA 510(k) clearance?

Motion Correction System received FDA 510(k) clearance on 2020-02-04, under 510(k) number K193324.

Who is the listed applicant for Motion Correction System?

The FDA 510(k) record lists Kineticor, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Motion Correction System?

The FDA product code for Motion Correction System is LNH.

Related Devices (Code: LNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253808AIR Recon DLGE Medical Systems K261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG K260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm Corporation K260746S-scan Open (100001800)Esaote, 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.