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FDA 510(k)

Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1

K-Number: K170177 · 2017-06-30

ApplicantToshibamedical Systems Corporation
Decision Date2017-06-30
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 is a medical device manufactured by Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2017-06-30 under approval number K170177. 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-305A/3) V8.3 with FIRST 2.1?

Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 is a medical device that received FDA 510(k) clearance on 2017-06-30. It is manufactured by Toshibamedical Systems Corporation. The 510(k) number is K170177.

When was Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 approved by the FDA?

Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 received FDA 510(k) clearance on 2017-06-30, under approval number K170177.

What company makes Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1?

Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 is manufactured by Toshibamedical Systems Corporation.

What is the FDA product code for Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1?

The FDA product code for Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 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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