# K053458: WEB1000

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Corp.
- Decided: Dec 22, 2005 after 9 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: 5 generations back to K913770 (1991). 9 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043415: Centricity Pacs System, Ge Medical Systems Information Technologies (2005) 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
- K071297: Impax SE Sigmacom Client (Pacs Workstation) (2007), 0 descendants of its own

## Recalls of this device
- May 14, 2007 · Not classified · Z-1243-2008: Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost.
- May 14, 2007 · Not classified · Z-1244-2008: Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost.

## Indications for use
AGFA's WEB1000 software is intended for installation on standard hardware meeting or exceeding minimum specifications. The system is intended for viewing, assembling, organizing, sharing, and displaying patient images and demographic information. The WEB1000 can be part of your evolving department solution and can also be used remotely over a hospital intranet or over the Internet. When used by trained and qualified professionals the WEB1000 may be used for reviewing and referral purposes of medical image data collected from various types of modalities, including mammography. When used for mammography the WEB1000 should never be used as a diagnostic tool.

Source page: https://510kreport.com/device/K053458
Methodology: https://510kreport.com/methodology