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FDA 510(k)

Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i

K-Number: K192832 · 2020-02-21

ApplicantCanon Medical Systems Corporation
Decision Date2020-02-21
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i is a medical device manufactured by Canon Medical Systems Corporation. It received FDA 510(k) clearance on 2020-02-21 under approval number K192832. 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 Prime SP (TSX-303B8) V10.2 with AiCE-i?

Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i is a medical device that received FDA 510(k) clearance on 2020-02-21. It is manufactured by Canon Medical Systems Corporation. The 510(k) number is K192832.

When was Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i approved by the FDA?

Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i received FDA 510(k) clearance on 2020-02-21, under approval number K192832.

What company makes Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i?

Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i is manufactured by Canon Medical Systems Corporation.

What is the FDA product code for Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i?

The FDA product code for Aquilion Prime SP (TSX-303B8) V10.2 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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