# K142316: IMPAX Agility

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare N.V.
- Decided: Jan 6, 2015 after 140 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: 11 generations back to K913770 (1991). 203 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 205 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111945: Impax Next Generation, Agfa Healthcare N.V. (2011) Summary page 4.
- K133135: Impax Volume Viewing 3.0, Agfa Healthcare N.V. (2014) Summary page 4.
- K123920: Syngo.Via, Siemens AG Medical Solutions (2013) Summary page 4.

## Most influential descendants
- K252199: AGFA HealthCare Enterprise Imaging (2025), 0 descendants of its own

## Indications for use
IMPAX Agility is a Picture Archiving and Communications System (PACS). It 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. IMPAX Agility is 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 and image registration 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, IMPAX Agility integrates with servers, archives, Radiology Information Systems (RIS), Hospital Information Systems (HIS), 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.

Source page: https://510kreport.com/device/K142316
Methodology: https://510kreport.com/methodology