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FDA 510(k)

Promaxo MRI System II

K-Number: K232361 · 2023-09-05

ApplicantPromaxo, Inc.
Decision Date2023-09-05
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Promaxo MRI System II is a medical device manufactured by Promaxo, Inc.. It received FDA 510(k) clearance on 2023-09-05 under approval number K232361. 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 II?

Promaxo MRI System II is a medical device that received FDA 510(k) clearance on 2023-09-05. It is manufactured by Promaxo, Inc.. The 510(k) number is K232361.

When was Promaxo MRI System II approved by the FDA?

Promaxo MRI System II received FDA 510(k) clearance on 2023-09-05, under approval number K232361.

What company makes Promaxo MRI System II?

Promaxo MRI System II is manufactured by Promaxo, Inc..

What is the FDA product code for Promaxo MRI System II?

The FDA product code for Promaxo MRI System II is LNH.

Other Devices by Promaxo, Inc.

K202518Promaxo MRI System

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Official Source

View on FDA Database →

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