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FDA 510(k)

Aquilion ONE (TSX-305A/3) V7.3

K-Number: K160587 · 2016-06-09

ApplicantToshibamedical Systems Corporation
Decision Date2016-06-09
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Aquilion ONE (TSX-305A/3) V7.3 is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2016-06-09 under 510(k) number K160587. 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) V7.3?

Aquilion ONE (TSX-305A/3) V7.3 is a medical device that received FDA 510(k) clearance on 2016-06-09. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K160587.

When did Aquilion ONE (TSX-305A/3) V7.3 receive FDA 510(k) clearance?

Aquilion ONE (TSX-305A/3) V7.3 received FDA 510(k) clearance on 2016-06-09, under 510(k) number K160587.

Who is the listed applicant for Aquilion ONE (TSX-305A/3) V7.3?

The FDA 510(k) record lists Toshibamedical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aquilion ONE (TSX-305A/3) V7.3?

The FDA product code for Aquilion ONE (TSX-305A/3) V7.3 is JAK.

Other records listing Toshibamedical Systems Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173962Viamo c100 TUS-VC100 Diagnostic Ultrasound SystemK173468Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0K173088Vitrea Software Toshiba Package VSTP-001AK173382Vantage Galan 3T, V4.6K173090Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4K172863Infinix-i, INFX-8000V, V7.0

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Related Devices (Code: JAK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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