# K120514: Cardiopacs

- Pathway: 510(k) (Abbreviated)
- Applicant: Lumedx
- Decided: Jul 5, 2012 after 135 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K842308 (1984). 57 ancestors in all.
No later device cites it as a predicate yet.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041581: Compacs, Version 1.0, Intelligent Images Srl (2004) Summary page 1.
- K102150: Syngo Dynamics, Version 9.0, Siemens Medical Solutions USA, Inc. (2010) Summary page 1.

## Indications for use
CardioPACS is a software device intended to be used by medical professionals, for storage, review, query/ retrieve, analysis and post processing of DICOM medical images as may be generated by echocardiography, radiology and other modalities. The device may be used as a stand-alone product, or in a networked system. CardioPACS is not intended to be used for reading of mammography images.

Source page: https://510kreport.com/device/K120514
Methodology: https://510kreport.com/methodology