# K071297: Impax SE Sigmacom Client (Pacs Workstation)

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare Corp.
- Decided: Jun 22, 2007 after 44 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: 6 generations back to K913770 (1991). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050751: Impax Orthopaedic Workstation, Model Impax ES 5.X, Agfa Corp. (2005) Summary page 1.
- K040555: Impax Client Embrace, Agfa Corp. (2004) Summary page 1.
- K053458: WEB1000, Agfa Corp. (2005) Summary page 1.

## Recalls of this device
- Sep 19, 2013 · Class II · Z-0035-2014: System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.

## Indications for use
The system is indicated for the storage, reading, interpretation, clinical review, analysis, annotation, distribution, printing, editing and processing of digital images and data acquired from any DICOM device by healthcare professionals, including radiologists, physicians, technologists and clinicians. - With the Teleradiology option it can be used to consult and share information with remote users. - With the Mammography option it can be used for screening and diagnosis (with MG, "For presentation" images only) from FDA approved modalities in softcopy and printed formats. - With the Orthopedic option it can be used to perform common orthopedic measurements of the hip, knee, spine (Coxometry, Gonometry, Lipman Cobb). - With the Slice Imaging option it can be used to process basic 3D rendering: MIP, MPR or series synchronization. - With the Quality Assurance option it can be used by PACS administrators or technologists to perform quality control activities related to patient images and data.

Source page: https://510kreport.com/device/K071297
Methodology: https://510kreport.com/methodology