# K022292: Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology Clinical Review Satation,Impax Ortho

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Corp.
- Decided: Sep 12, 2002 after 59 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K913475 (1991). 6 ancestors in all.
48 later devices descend from it; 12 cite it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973983: Phillips Easy Vision Family Workstation Option Endo 3D, Philips Medical Systems, Inc. (1998) Summary page 2.
- K971965: Philips Easyvision, Philips Medical Systems, Inc. (1998) Summary page 2.

## Most influential descendants
- K061421: Erad Pacs (2006), 14 descendants of its own
- K050228: Agfa Heartlab Cardiovascular (2005), 9 descendants of its own
- K120995: Erad Pacs/Erad Ris/Pacs/Erad Epvlite Viewer Software Product (2012), 7 descendants of its own
- K053133: Syngo Dynamics, Version 5.0 (2005), 7 descendants of its own
- K143397: ICIS View (2015), 6 descendants of its own

## Recalls of this device
- Apr 5, 2011 · Not classified · Z-2246-2011: Software issue that occurs after dictation of a study.
- Jul 16, 2009 · Not classified · Z-1887-2009: Measurements are inaccurate on multiple workstations.
- Dec 24, 2008 · Not classified · Z-0945-2009: Polling procedure may fail when multiple merge/split is carried out.
- Jun 4, 2008 · Not classified · Z-2180-2008: The IMPAX client failed to "refresh" the image area upon receiving a study retrieved from archive. The system also erroneously displays this study retrieved from archive as the "active" study.
- 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.
- Feb 15, 2007 · Not classified · Z-1307-2008: Misidentification: The orthopedic planning X-ray images for one patient are misidentified as the images for another patient.
- Aug 8, 2006 · Not classified · Z-0033-2007: Failed CAD displayed as 'No Findings'
- Jun 30, 2006 · Not classified · Z-1256-06: Possible corrupted image appearing after System Start.

## Indications for use
IMPAX@Workstations with MPR, Digital Subtraction and 3D options are intended for use in the acquisition, display, digital processing, review, transfer, storage, archiving and printing of medical images and patient demographic information. They are indicated for use by the physician to aid in diagnosis, and by medical professionals whenever they would require or desire access to medical images and patient demographic information. MPR and 3D functions allow the user to view 3D image data from perspectives different from that in which it was acquired. Digital subtraction allows a user viewing time series studies to remove densities not enhanced by a contrast medium, highlighting vascular structures.

Source page: https://510kreport.com/device/K022292
Methodology: https://510kreport.com/methodology