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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 a medical device manufactured by Esaote, S.p.A.. It received FDA 510(k) clearance on 2016-01-08 under approval 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. It is manufactured by Esaote, S.p.A.. The 510(k) number is K153039.

When was MRI Dynamic Analysis Plus approved by the FDA?

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

What company makes MRI Dynamic Analysis Plus?

MRI Dynamic Analysis Plus is manufactured by Esaote, S.p.A..

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

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

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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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