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FDA 510(k)

Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE

K-Number: K182901 · 2019-07-05

ApplicantCanon Medical Systems Corporation
Decision Date2019-07-05
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2019-07-05 under approval number K182901. 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/1 and /2) V8.8 with AiCE?

Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE is a medical device that received FDA 510(k) clearance on 2019-07-05. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K182901.

When was Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE approved by the FDA?

Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE received FDA 510(k) clearance on 2019-07-05, under approval number K182901.

What company makes Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE?

Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE?

The FDA product code for Aquilion Precision (TSX-304A/1 and /2) V8.8 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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