# K252199: AGFA HealthCare Enterprise Imaging

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare N.V.
- Decided: Oct 15, 2025 after 93 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K913770 (1991). 232 ancestors in all.
No later device cites it as a predicate yet.
3 of 233 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133135: Impax Volume Viewing 3.0, Agfa Healthcare N.V. (2014) Summary page 6.
- K142316: IMPAX Agility, Agfa Healthcare N.V. (2015) Summary page 6.
- K170434: Enterprise Imaging XERO Viewer 8.1, Agfa Healthcare N.V. (2017) Summary page 6.

## Indications for use
Enterprise Imaging Desktops when deployed as a departmental Picture Archiving and Communications System (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks. Enterprise Imaging Desktops are intended to be used by trained healthcare professionals including, but not limited to physicians, radiologists, orthopaedic surgeons, cardiologists, mammographers, technologists, and clinicians for diagnosis and treatment planning using DICOM compliant medical images and other healthcare data. MPR, MIP and 3D rendering functionality allows the user to view image data from perspectives different from that in which it was acquired. Other digital image processing functionality such as multi-scale window leveling, image registration and segmentation can be used to enhance image viewing. Automatic spine labelling provides the capability to semi-automatically label vertebrae or disks. As a comprehensive imaging suite, Enterprise Imaging Desktops integrates with servers, archives, Radiology Information Systems (RIS), Cardiology Information Systems (CIS), Hospital Information Systems (HIS), Electronic Patient Records (EPR), reporting and 3rd party applications for customer specific workflows. 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 mammographic use. When deployed as a hospital-wide Solution (Enterprise Imaging for Multispecialty Departments), Agfa HealthCare’s Enterprise Imaging Desktops provides order generation, image acquisition, quality control, image reading, reporting, and review workflows for departments that have no such systems available including (but not limited to) dermatology, ophthalmology, gastroenterology, dental and general hospital use. AGFA HealthCare’s Enterprise Imaging XERO Viewer is a software application used for reference and diagnostic viewing of multispecialty 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 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 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 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/K252199
Methodology: https://510kreport.com/methodology