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FDA 510(k)

MR Elastography; MZEK-001A

K-Number: K220018 · 2022-03-03

ApplicantCanon Medical Systems Corporation
Decision Date2022-03-03
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MR Elastography; MZEK-001A is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2022-03-03 under approval number K220018. 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 MR Elastography; MZEK-001A?

MR Elastography; MZEK-001A is a medical device that received FDA 510(k) clearance on 2022-03-03. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K220018.

When was MR Elastography; MZEK-001A approved by the FDA?

MR Elastography; MZEK-001A received FDA 510(k) clearance on 2022-03-03, under approval number K220018.

What company makes MR Elastography; MZEK-001A?

MR Elastography; MZEK-001A is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for MR Elastography; MZEK-001A?

The FDA product code for MR Elastography; MZEK-001A 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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