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FDA 510(k)

Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I

K-Number: K203042 · 2020-12-10

ApplicantCanon Medical Systems Corporation
Decision Date2020-12-10
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2020-12-10 under approval number K203042. 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 Exceed LB (TSX-202A/3) V10.6 with AiCE-I?

Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I is a medical device that received FDA 510(k) clearance on 2020-12-10. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K203042.

When was Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I approved by the FDA?

Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I received FDA 510(k) clearance on 2020-12-10, under approval number K203042.

What company makes Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I?

Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I?

The FDA product code for Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I 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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