# K111638: Impax Volume Viewing

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare N.V.
- Decided: Jun 24, 2011 after 11 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: 2 generations back to K043441 (2005). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080013: Registration and Fusion, Agfa Healthcare Corporation (2008) Summary page 1.
- K070831: Voxar 3D Enterprise with Colonmetrix and Pet/CT Perfusion, Barcoview Mis Edinburgh (2007) Summary page 1.

## Most influential descendants
- K133135: Impax Volume Viewing 3.0 (2014), 3 descendants of its own
- K142316: IMPAX Agility (2015), 1 descendant of its own
- K252199: AGFA HealthCare Enterprise Imaging (2025), 0 descendants of its own
- K161061: IMPAX Volume Viewing 4.0 (2016), 0 descendants of its own

## Indications for use
Impax Volume Viewing is a visualization package for PACS workstations. It is intended to support radiographer, medical imaging technician, radiologist and referring physician in the reading, analysis and diagnosis of DICOM compliant velumetric medical datasets. The software is intended as a general purpose digital medical image processing tool, with optional functionality to facilitate visualization and measurement of vessel features. Other optional functionality is intended for the registration of anatomical (CT) on functional volumetric image data {MR) to facilitate the comparison of various lesions. Volume and distance measurements are intended for evaluation and quantification of tumor measurements, and other analysis and evaluation of both hard and soft tissues. The software also supports interactive segmentation-of a region of interest (ROI).

Source page: https://510kreport.com/device/K111638
Methodology: https://510kreport.com/methodology