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FDA 510(k)

TCL3 Motion Tracking System

K-Number: K221785 · 2022-08-29

ApplicantTracinnovations A/S
Decision Date2022-08-29
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TCL3 Motion Tracking System is the device name listed in this FDA 510(k) record. The listed applicant is Tracinnovations A/S. It received FDA 510(k) clearance on 2022-08-29 under 510(k) number K221785. 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 TCL3 Motion Tracking System?

TCL3 Motion Tracking System is a medical device that received FDA 510(k) clearance on 2022-08-29. The listed applicant is Tracinnovations A/S. The 510(k) number is K221785.

When did TCL3 Motion Tracking System receive FDA 510(k) clearance?

TCL3 Motion Tracking System received FDA 510(k) clearance on 2022-08-29, under 510(k) number K221785.

Who is the listed applicant for TCL3 Motion Tracking System?

The FDA 510(k) record lists Tracinnovations A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TCL3 Motion Tracking System?

The FDA product code for TCL3 Motion Tracking 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 SystemsK261331I-Genius (100019400)Esaote, S.p.A.K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AGK260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.K253862APERTO Lucent MRI SystemFujifilm CorporationK260746S-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.

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