# K040555: Impax Client Embrace

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Corp.
- Decided: May 26, 2004 after 85 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K913770 (1991). 5 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033400: Seno Advantage, Ge Medical Systems W-400 (2003) Summary page 1.

## Most influential descendants
- K081976: Impax MA3000 Diagnostic Pacs Workstation (2008), 4 descendants of its own
- K111945: Impax Next Generation (2011), 2 descendants of its own
- K142316: IMPAX Agility (2015), 1 descendant of its own
- K252199: AGFA HealthCare Enterprise Imaging (2025), 0 descendants of its own
- K120305: Thinkingnet, Thinkingpacs/Ris - Proprietary Name Fro Thinkingnet, Thinkingarchive (or Nupax) - the Management and Archiv (2012), 0 descendants of its own

## Recalls of this device
- Jun 28, 2007 · Not classified · Z-1245-2008: Text and Images may not be synchronized.
- 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
The Embrace TM DS3000 Diagnostic PACS Workstation is intended for use with regionally approved digital mammography modalities presenting processed images (DICOM "For Presentation" images) and the display of multi-modality general imaging DICOM images including adjunct breast imaging modality studies (i.e. Breast MR and Breast US). The Embrace TM DS3000 Diagnostic PACS Workstation when intended for diagnostic/screening Mammography viewing must do so only when used with FDA approved monitors and only when viewing Lossless format images. The Embrace TM DS3000 Diagnostic PACS Workstation is also intended for softcopy reading and diagnosis by Radiologists.

Source page: https://510kreport.com/device/K040555
Methodology: https://510kreport.com/methodology