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FDA 510(k)

NEONA 1.5T MRI System

K-Number: K222259 · 2023-02-21

ApplicantTime Medical Limited
Decision Date2023-02-21
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NEONA 1.5T MRI System is a medical device manufactured by Time Medical Limited. It received FDA 510(k) clearance on 2023-02-21 under approval number K222259. 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 NEONA 1.5T MRI System?

NEONA 1.5T MRI System is a medical device that received FDA 510(k) clearance on 2023-02-21. It is manufactured by Time Medical Limited. The 510(k) number is K222259.

When was NEONA 1.5T MRI System approved by the FDA?

NEONA 1.5T MRI System received FDA 510(k) clearance on 2023-02-21, under approval number K222259.

What company makes NEONA 1.5T MRI System?

NEONA 1.5T MRI System is manufactured by Time Medical Limited.

What is the FDA product code for NEONA 1.5T MRI System?

The FDA product code for NEONA 1.5T MRI System is LNH.

Other Devices by Time Medical Limited

K183621EMMA 1.5T MRI System

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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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