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FDA 510(k)

MRI Dynamic Analysis Plus

K-Number: K153039 · 2016-01-08

ApplicantEsaote, S.p.A.
Decision Date2016-01-08
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRI Dynamic Analysis Plus is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2016-01-08 under 510(k) number K153039. 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 MRI Dynamic Analysis Plus?

MRI Dynamic Analysis Plus is a medical device that received FDA 510(k) clearance on 2016-01-08. The listed applicant is Esaote, S.p.A.. The 510(k) number is K153039.

When did MRI Dynamic Analysis Plus receive FDA 510(k) clearance?

MRI Dynamic Analysis Plus received FDA 510(k) clearance on 2016-01-08, under 510(k) number K153039.

Who is the listed applicant for MRI Dynamic Analysis Plus?

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

What is the FDA product code for MRI Dynamic Analysis Plus?

The FDA product code for MRI Dynamic Analysis Plus is LNH.

Other records listing Esaote, S.p.A. 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.

K261331I-Genius (100019400)K2532886450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)K260746S-scan Open (100001800)K251901Magnifico Open (100009900)K2533107600 Ultrasound System (MyLabC25); 7600 Ultrasound System (MyLabC30)K2432536600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)

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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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