# K111945: Impax Next Generation

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare N.V.
- Decided: Aug 5, 2011 after 28 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: 6 generations back to K913770 (1991). 31 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022292: Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology Clinical Review Satation,Impax Ortho, Agfa Corp. (2002) Summary page 1.
- K071972: Orthopedic Software for Impax Workstations, Agfa Healthcare Corp. (2007) Summary page 1.
- K081976: Impax MA3000 Diagnostic Pacs Workstation, Agfa Healthcare Corporation (2008) Summary page 2.

## Most influential descendants
- K142316: IMPAX Agility (2015), 1 descendant of its own
- K252199: AGFA HealthCare Enterprise Imaging (2025), 0 descendants of its own

## Recalls of this device
- Aug 3, 2018 · Class II · Z-0101-2019: Adding an additional comparison study to the Clinical Side Bar in the Enterprise Imaging Diagnostics Desktop, can result in a change of the sort order of the studies in the Clinical Side Bar. The thum
- Jan 8, 2014 · Class II · Z-0919-2014: Patient name displayed (printed) on the Patient Report was the wrong patient name.

## Indications for use
Agfa's IMPAX Next Generation isa 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 Next Generation isintended to be used by trained healthcare professionals including, but not limited to physicians, radiologists, orthopaedlic 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. As acomprehensive imaging suite, IMPAX Next Generation 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/K111945
Methodology: https://510kreport.com/methodology