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FDA 510(k)

Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System

K-Number: K192828 · 2020-02-13

ApplicantCanon Medical Systems Corporation
Decision Date2020-02-13
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2020-02-13 under approval number K192828. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System?

Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System is a medical device that received FDA 510(k) clearance on 2020-02-13. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K192828.

When was Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System approved by the FDA?

Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System received FDA 510(k) clearance on 2020-02-13, under approval number K192828.

What company makes Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System?

Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System?

The FDA product code for Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System is JAK.

Related Clinical Trials

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Related PubMed Literature

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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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