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FDA 510(k)

Vantage Galan 3T, MRT-3020/A9, V5.0

K-Number: K183657 · 2019-03-15

ApplicantCanon Medical Systems Corporation
Decision Date2019-03-15
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vantage Galan 3T, MRT-3020/A9, V5.0 is the device name listed in this FDA 510(k) record. The listed applicant is Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2019-03-15 under 510(k) number K183657. 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/A9, V5.0?

Vantage Galan 3T, MRT-3020/A9, V5.0 is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Canon Medical Systems Corporation. The 510(k) number is K183657.

When did Vantage Galan 3T, MRT-3020/A9, V5.0 receive FDA 510(k) clearance?

Vantage Galan 3T, MRT-3020/A9, V5.0 received FDA 510(k) clearance on 2019-03-15, under 510(k) number K183657.

Who is the listed applicant for Vantage Galan 3T, MRT-3020/A9, V5.0?

The FDA 510(k) record lists Canon Medical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vantage Galan 3T, MRT-3020/A9, V5.0?

The FDA product code for Vantage Galan 3T, MRT-3020/A9, V5.0 is LNH.

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Related Devices (Code: 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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