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FDA 510(k)

MyoStrain 5.1

K-Number: K182756 · 2019-02-14

ApplicantMyocardial Solutions
Decision Date2019-02-14
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MyoStrain 5.1 is the device name listed in this FDA 510(k) record. The listed applicant is Myocardial Solutions. It received FDA 510(k) clearance on 2019-02-14 under 510(k) number K182756. 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 MyoStrain 5.1?

MyoStrain 5.1 is a medical device that received FDA 510(k) clearance on 2019-02-14. The listed applicant is Myocardial Solutions. The 510(k) number is K182756.

When did MyoStrain 5.1 receive FDA 510(k) clearance?

MyoStrain 5.1 received FDA 510(k) clearance on 2019-02-14, under 510(k) number K182756.

Who is the listed applicant for MyoStrain 5.1?

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

What is the FDA product code for MyoStrain 5.1?

The FDA product code for MyoStrain 5.1 is LNH.

Other records listing Myocardial Solutions as applicant

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.

K241607MyoStrain (6.0)

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

View on FDA Database →

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

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