Enterprise Imaging XERO Viewer 8.1

• • Ongoing Z-0055-2025 FDA Class II ·initiated 6 Sep 2024

  Software defect, when an image has non-square pixel spacing, the reference/localizer line is incorrectly placed on the scout image in the XERO Viewet, may display the incorrect crosshair/line position on the non-coplanar/scout image with respect to the axial slice location. Inaccurate placement of reference lines or crosshairs have potential risk of misdiagnosis or mistreatment due to unintended shifts in the display of anatomical locations.

• • Ongoing Z-1004-2023 FDA Class II ·initiated 5 Dec 2022

  There is a software defect that can cause issues with images.

510(k) Number

K170434 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• DX-D Imaging Package

  Class II

  FDA 510(k) K172784 Active Cleared 13 Oct 2017

• DR 800 with MUSICA Dynamic Open recall

  Class II

  FDA 510(k) K180589 Active Cleared 5 Apr 2018

• ICIS View

  Class II

  FDA 510(k) K143397 Active Cleared 1 Jun 2015

• IMPAX Agility

  Class II

  FDA 510(k) K142316 Active Cleared 6 Jan 2015

• Agfa Computed Radiography Systems with Dx-G Digitizers

  Class II

  FDA 510(k) K092238 Active Cleared 11 Aug 2009

• IMPAX Volume Viewing 4.0

  Class II

  FDA 510(k) K161061 Active Cleared 22 Jun 2016

See all devices from Agfa Healthcare N.V. →

• What types of medical images can the Enterprise Imaging XERO Viewer 8.1 analyze and display?

  The Enterprise Imaging XERO Viewer 8.1 is specifically designed to view, analyze, and manage radiographic and other digital imaging studies. This includes standard X-ray images, but it may also support other digital modalities depending on institutional integration, such as CT scans, MRIs (if the system is configured to handle them), and ultrasound images. The software provides tools for radiologists and healthcare professionals to interpret these images, measure anatomical structures, and annotate findings within a clinical workflow.

• How is the Enterprise Imaging XERO Viewer 8.1 supplied, and does it require physical sterilization or single-use considerations?

  The Enterprise Imaging XERO Viewer 8.1 is supplied exclusively as a digital software application for installation on compatible medical imaging workstations. Since it is software-based, there are no physical components that require sterilization or single-use considerations. It operates entirely within standard IT infrastructure and does not involve any consumable or disposable materials.

• Is the Enterprise Imaging XERO Viewer 8.1 compatible with MRI environments, and what safety considerations should be noted?

  The Enterprise Imaging XERO Viewer 8.1 does not contain any MRI-unsafe components, meaning it does not introduce electromagnetic interference or pose a risk in MRI environments. However, its use is governed by institutional IT policies and imaging protocols, so clinicians should confirm compatibility with their specific MRI systems and workflows before implementation. The software itself is not an MRI device but is designed to integrate with imaging systems used in radiology departments.

• What regulatory pathways does the Enterprise Imaging XERO Viewer 8.1 follow in the U.S. and the EU?

  In the U.S., the Enterprise Imaging XERO Viewer 8.1 is cleared through the FDA’s 510(k) process, specifically under the Traditional clearance type with a decision code of SESE (Substantially Equivalent). This means it was determined to be substantially equivalent to a legally marketed predicate device. In the EU, it complies with the Medical Device Regulation (MDR), ensuring it meets the necessary safety, performance, and regulatory requirements for use within the European market.

• What types of measurements and annotations can be performed using the Enterprise Imaging XERO Viewer 8.1?

  The software provides tools for radiologists and healthcare professionals to measure anatomical structures directly on digital images, which is useful for assessing dimensions, distances, or areas of interest. Additionally, it supports annotation features, allowing users to add notes, labels, or markings to findings within the images. These capabilities are integrated into the clinical workflow to enhance diagnostic accuracy and documentation.