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FDA 510(k)

Vantage Orian 1.5T, MRT-1550, V4.5

K-Number: K191662 · 2019-07-23

ApplicantCanon Medical Systems Corporation
Decision Date2019-07-23
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vantage Orian 1.5T, MRT-1550, V4.5 is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2019-07-23 under approval number K191662. 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 Orian 1.5T, MRT-1550, V4.5?

Vantage Orian 1.5T, MRT-1550, V4.5 is a medical device that received FDA 510(k) clearance on 2019-07-23. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K191662.

When was Vantage Orian 1.5T, MRT-1550, V4.5 approved by the FDA?

Vantage Orian 1.5T, MRT-1550, V4.5 received FDA 510(k) clearance on 2019-07-23, under approval number K191662.

What company makes Vantage Orian 1.5T, MRT-1550, V4.5?

Vantage Orian 1.5T, MRT-1550, V4.5 is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Vantage Orian 1.5T, MRT-1550, V4.5?

The FDA product code for Vantage Orian 1.5T, MRT-1550, V4.5 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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