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FDA 510(k)

Vantage Elan 1.5T, MRT-2020, V6.0

K-Number: K210164 · 2021-03-10

ApplicantCanon Medical Systems Corporation
Decision Date2021-03-10
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vantage Elan 1.5T, MRT-2020, V6.0 is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2021-03-10 under approval number K210164. 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 Vantage Elan 1.5T, MRT-2020, V6.0?

Vantage Elan 1.5T, MRT-2020, V6.0 is a medical device that received FDA 510(k) clearance on 2021-03-10. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K210164.

When was Vantage Elan 1.5T, MRT-2020, V6.0 approved by the FDA?

Vantage Elan 1.5T, MRT-2020, V6.0 received FDA 510(k) clearance on 2021-03-10, under approval number K210164.

What company makes Vantage Elan 1.5T, MRT-2020, V6.0?

Vantage Elan 1.5T, MRT-2020, V6.0 is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Vantage Elan 1.5T, MRT-2020, V6.0?

The FDA product code for Vantage Elan 1.5T, MRT-2020, V6.0 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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