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FDA 510(k)

IMRIS iMRI 3T V

K-Number: K212367 · 2021-08-23

ApplicantDeerfield Imaging, Inc.
Decision Date2021-08-23
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMRIS iMRI 3T V is a medical device manufactured by Deerfield Imaging, Inc.. It received FDA 510(k) clearance on 2021-08-23 under approval number K212367. 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 IMRIS iMRI 3T V?

IMRIS iMRI 3T V is a medical device that received FDA 510(k) clearance on 2021-08-23. It is manufactured by Deerfield Imaging, Inc.. The 510(k) number is K212367.

When was IMRIS iMRI 3T V approved by the FDA?

IMRIS iMRI 3T V received FDA 510(k) clearance on 2021-08-23, under approval number K212367.

What company makes IMRIS iMRI 3T V?

IMRIS iMRI 3T V is manufactured by Deerfield Imaging, Inc..

What is the FDA product code for IMRIS iMRI 3T V?

The FDA product code for IMRIS iMRI 3T V 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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