XIDF-AWS801, Angio Workstation, V6.10

• • Terminated Z-2188-2016 FDA Class II ·initiated 24 Feb 2016

  During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found that the software incorrectly calculated the PSD value when the x-ray condition of the frontal plane and the lateral plane are the same. It incorrectly used in the calculation a dose value from a previous exposure.

510(k) Number

K150967 ↗

FDA Product Code

OWB

Device Class

Class II

Regulation

21 CFR Part 892.1650

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What is the XIDF-AWS801, Angio Workstation, V6.10 used for?

  The XIDF-AWS801, Angio Workstation, V6.10 is a software-based workstation used in interventional radiology and cardiology settings to receive 2D/3D image data from connected angiography systems and perform parametric imaging to visualize vessel flow and contrast dynamics.

• How is the XIDF-AWS801, Angio Workstation, V6.10 supplied and what is its physical form?

  The device is supplied as a software workstation for use in clinical imaging environments, meaning it is not a physical hardware device but a software application that runs on compatible computing systems to process angiography image data.

• Is the XIDF-AWS801, Angio Workstation, V6.10 sterile or intended for single-use?

  The device data provides no indication of sterility or single-use status; as a software-based workstation, it is not a physical item that would be sterilized or disposed of after use, and no such claims are made in the provided information.

• What regulatory pathway was used for the XIDF-AWS801, Angio Workstation, V6.10 and what is its classification?

  The device received traditional 510(k) clearance (K150967) as substantially equivalent to a predicate device and is classified as a Class II Interventional Fluoroscopic X-Ray System under FDA regulation number 892.1650.

• What type of image data does the XIDF-AWS801, Angio Workstation, V6.10 process and what specific function does it perform?

  The device receives 2D/3D image data from connected angiography systems and performs parametric imaging to visualize vessel flow and contrast dynamics, which supports diagnostic and interventional procedures in radiology and cardiology.