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FDA 510(k)

EMMA 1.5T MRI System

K-Number: K183621 · 2019-02-22

ApplicantTime Medical Limited
Decision Date2019-02-22
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EMMA 1.5T MRI System is a medical device manufactured by Time Medical Limited. It received FDA 510(k) clearance on 2019-02-22 under approval number K183621. 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 EMMA 1.5T MRI System?

EMMA 1.5T MRI System is a medical device that received FDA 510(k) clearance on 2019-02-22. It is manufactured by Time Medical Limited. The 510(k) number is K183621.

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

EMMA 1.5T MRI System received FDA 510(k) clearance on 2019-02-22, under approval number K183621.

What company makes EMMA 1.5T MRI System?

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

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

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

Other Devices by Time Medical Limited

K222259NEONA 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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