# K041029: Kinetdx

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Jul 8, 2004 after 78 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: 4 generations back to K950279 (1995). 8 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023772: Kinetdx Picture Archiving and Communications System, Acuson Corp. (2002) Summary page 2.
- K992259: Echocardiography System Series 95000, Camtronics, Ltd. (1999) Summary page 2.

## Most influential descendants
- K053133: Syngo Dynamics, Version 5.0 (2005), 7 descendants of its own
- K111319: Ibis Explorer and Markup Software (2011), 6 descendants of its own
- K122205: EXINI (2012), 5 descendants of its own
- K050943: GE Viewpoint (2005), 3 descendants of its own
- K191262: aBSI (2019), 2 descendants of its own

## Recalls of this device
- Apr 6, 2006 · Not classified · Z-1235-06: The cardiologist's report comments may not be retained by the system due to a software bug.

## Indications for use
The intended use of the KinetDx system is for the acceptance, transfer, display, storage, and post-processing of digital medical images, including manipulation and quantification.

Source page: https://510kreport.com/device/K041029
Methodology: https://510kreport.com/methodology