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

• • Ongoing Z-1725-2020 FDA Class II ·initiated 25 Mar 2019

  Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.

510(k) Number

K173468 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is the Aquilion Precision CT scanner used for?

  The Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 is a computed tomography x-ray system designed to produce detailed cross-sectional images of the body for medical evaluation and diagnostic imaging purposes.

• How is the Aquilion Precision CT scanner supplied?

  The device is supplied as a Class II medical device under product code JAK, manufactured by Toshiba Medical Systems Corporation. The data does not specify whether it is single-use or reusable, nor does it provide information about sterility or MRI safety.

• What are the regulatory details for the Aquilion Precision CT scanner?

  The Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 received FDA 510(k) clearance with number K173468 on February 23, 2018. It was determined to be substantially equivalent to predicate devices and reviewed by the Radiology advisory committee.

• Are there different models or sizes available for the Aquilion Precision CT scanner?

  The specific model referenced is Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0. The device data does not indicate whether multiple sizes or configurations are available beyond this specific model designation.