# K081976: Impax MA3000 Diagnostic Pacs Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare Corporation
- Decided: Jul 28, 2008 after 17 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (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). 13 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040555: Impax Client Embrace, Agfa Corp. (2004) Summary page 1.
- K043146: Horizon Medical Imaging, Mckesson Medical Imaging Company (2005) Summary page 1.

## Most influential descendants
- 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
- Oct 22, 2010 · Not classified · Z-0835-2011: Product did not receive UL Certification

## Indications for use
The IMPAX MA3000 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 IMPAX MA3000 Diagnostic PACS Workstation when intended for diagnostic/screening Mammography viewing must do so only when used with FDA cleared monitors and only when viewing Lossless format images. The IMPAX MA3000 Diagnostic PACS Workstation is also intended for soft and hardcopy reading and diagnosis by Radiologists.

Source page: https://510kreport.com/device/K081976
Methodology: https://510kreport.com/methodology