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FDA 510(k)

Promaxo MRI System

K-Number: K202518 · 2021-03-03

ApplicantPromaxo, Inc.
Decision Date2021-03-03
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Promaxo MRI System is a medical device manufactured by Promaxo, Inc.. It received FDA 510(k) clearance on 2021-03-03 under approval number K202518. 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 Promaxo MRI System?

Promaxo MRI System is a medical device that received FDA 510(k) clearance on 2021-03-03. It is manufactured by Promaxo, Inc.. The 510(k) number is K202518.

When was Promaxo MRI System approved by the FDA?

Promaxo MRI System received FDA 510(k) clearance on 2021-03-03, under approval number K202518.

What company makes Promaxo MRI System?

Promaxo MRI System is manufactured by Promaxo, Inc..

What is the FDA product code for Promaxo MRI System?

The FDA product code for Promaxo MRI System is LNH.

Other Devices by Promaxo, Inc.

K232361Promaxo MRI System II

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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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