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FDA 510(k)

Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0

K-Number: K173468 · 2018-02-23

ApplicantToshibamedical Systems Corporation
Decision Date2018-02-23
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 is a medical device manufactured by Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2018-02-23 under approval number K173468. 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/2) V8.6 with FIRST 3.0?

Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 is a medical device that received FDA 510(k) clearance on 2018-02-23. It is manufactured by Toshibamedical Systems Corporation. The 510(k) number is K173468.

When was Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 approved by the FDA?

Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 received FDA 510(k) clearance on 2018-02-23, under approval number K173468.

What company makes Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0?

Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 is manufactured by Toshibamedical Systems Corporation.

What is the FDA product code for Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0?

The FDA product code for Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 is JAK.

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Related PubMed Literature

PMID: 41543941 Opportunities and Challenges in Precision Neurotherapeutics. Annual review of biomedical engineering (2026)

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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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