# K170434: Enterprise Imaging XERO Viewer 8.1

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare N.V.
- Decided: Jul 3, 2017 after 140 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K954874 (1996). 73 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151774: CARESTREAM Vue Motion, Carestream Health, Inc. (2015) Summary page 4.
- K143397: ICIS View, Agfa Healthcare N.V. (2015) Summary page 4.

## Most influential descendants
- K200822: Braid (2020), 1 descendant of its own
- K252199: AGFA HealthCare Enterprise Imaging (2025), 0 descendants of its own
- K231385: Rology Teleradiology Platform (v.1.22.1103) (2023), 0 descendants of its own

## Recalls of this device
- Sep 6, 2024 · Class II · Z-0055-2025: 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
- Dec 5, 2022 · Class II · Z-1004-2023: There is a software defect that can cause issues with images.

## Indications for use
Agfa HealthCare’s Enterprise Imaging XERO Viewer 8.1 is a software application used for reference and diagnostic viewing of multi-specialty medical imaging and non-imaging data with associated reports and documents and, as such, fulfills a key role in the Enterprise Imaging solution. XERO Viewer 8.1 enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data from multiple departments and organizations within one multi-disciplinary viewer. XERO Viewer 8.1 allows users to perform image manipulations (including window/level, markups, 3D visualization) and measurements. When images are reviewed and used as an element of diagnosis, it is the responsibility of the trained physician to determine if the image quality is suitable for their clinical application. Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed or non-lossy compressed “for presentation” images may be used for diagnosis or screening on monitors that are FDA-cleared for their intended use. XERO Viewer 8.1 can optionally be configured for Full Fidelity Mobile, which is intended for mobile diagnostic use, review and analysis of CR, DX, CT, MR, US, ECG images and medical reports. XERO Viewer Full Fidelity Mobile is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. XERO Viewer Full Fidelity Mobile is not intended for the display of mammography images for diagnosis.

Source page: https://510kreport.com/device/K170434
Methodology: https://510kreport.com/methodology