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FDA 510(k)

Aquilion ONE (TSX-308A/3) V1.5

K-Number: K242403 · 2024-12-23

ApplicantCanon Medical Systems Corporation
Decision Date2024-12-23
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aquilion ONE (TSX-308A/3) V1.5 is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2024-12-23 under approval number K242403. 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-308A/3) V1.5?

Aquilion ONE (TSX-308A/3) V1.5 is a medical device that received FDA 510(k) clearance on 2024-12-23. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K242403.

When was Aquilion ONE (TSX-308A/3) V1.5 approved by the FDA?

Aquilion ONE (TSX-308A/3) V1.5 received FDA 510(k) clearance on 2024-12-23, under approval number K242403.

What company makes Aquilion ONE (TSX-308A/3) V1.5?

Aquilion ONE (TSX-308A/3) V1.5 is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Aquilion ONE (TSX-308A/3) V1.5?

The FDA product code for Aquilion ONE (TSX-308A/3) V1.5 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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