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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 the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2017-06-30 under 510(k) 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. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K170177.

When did Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 receive FDA 510(k) clearance?

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

Who is the listed applicant for Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1?

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) V8.3 with FIRST 2.1?

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

K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLCK253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationK253649Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd.

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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