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FDA 510(k)

Aquilion Precision (TSX-304A/4) V10.14 with AiCE

K-Number: K223726 · 2023-03-07

ApplicantCanon Medical Systems Corporation
Decision Date2023-03-07
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aquilion Precision (TSX-304A/4) V10.14 with AiCE is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2023-03-07 under approval number K223726. 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 Precision (TSX-304A/4) V10.14 with AiCE?

Aquilion Precision (TSX-304A/4) V10.14 with AiCE is a medical device that received FDA 510(k) clearance on 2023-03-07. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K223726.

When was Aquilion Precision (TSX-304A/4) V10.14 with AiCE approved by the FDA?

Aquilion Precision (TSX-304A/4) V10.14 with AiCE received FDA 510(k) clearance on 2023-03-07, under approval number K223726.

What company makes Aquilion Precision (TSX-304A/4) V10.14 with AiCE?

Aquilion Precision (TSX-304A/4) V10.14 with AiCE is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Aquilion Precision (TSX-304A/4) V10.14 with AiCE?

The FDA product code for Aquilion Precision (TSX-304A/4) V10.14 with AiCE is JAK.

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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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