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FDA 510(k)

Vantage Galan 3T, MRT-3020/A7, V5.0

K-Number: K181593 · 2018-08-13

ApplicantCanon Medical Systems Corporation
Decision Date2018-08-13
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vantage Galan 3T, MRT-3020/A7, V5.0 is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2018-08-13 under approval number K181593. 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 Galan 3T, MRT-3020/A7, V5.0?

Vantage Galan 3T, MRT-3020/A7, V5.0 is a medical device that received FDA 510(k) clearance on 2018-08-13. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K181593.

When was Vantage Galan 3T, MRT-3020/A7, V5.0 approved by the FDA?

Vantage Galan 3T, MRT-3020/A7, V5.0 received FDA 510(k) clearance on 2018-08-13, under approval number K181593.

What company makes Vantage Galan 3T, MRT-3020/A7, V5.0?

Vantage Galan 3T, MRT-3020/A7, V5.0 is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Vantage Galan 3T, MRT-3020/A7, V5.0?

The FDA product code for Vantage Galan 3T, MRT-3020/A7, V5.0 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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