# K201060: Cordiana Dx16

- Pathway: 510(k) (Traditional)
- Applicant: Cordiana Medical Informatics AG
- Decided: Nov 16, 2020 after 209 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K921669 (1993). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152993: MUSE Cardiology Information System, Ge Medical Systems Information Technologies, Inc. (2016) Summary page 4.

## Indications for use
Cordiana Dx16 is a web-based software system used for reference and diagnostic viewing, manual editing and printing of cardiopulmonary records, consisting of measurements, text and digitized waveforms, with associated reports and documents. Users do not need to download or install any additional software or plug-ins to use the zero-footprint browser client. Cordiana Dx16 provides authenticated users the ability to search for, list, display, edit and confirm cardiopulmonary studies through the use of reviewing, onscreen measuring and editing tools. Cordiana Dxl 6 is intended for use by healthcare professionals, including (but not limited to) physicians, nurses and medical technicians, trained on the use of the software. Cordiana Dx16 is intended to be used in hospitals or facilities providing patient care, where cardiopulmonary studies are stored in a remote storage system, such as a Picture Archive and Communication System (PACS), with which records, reports and documents can be queried, retrieved and stored using DICOM or similar interface standards. Cordiana Dx 16 does not provide storage of records or associated reports and documents, does not modify the original record and waveform information, and is not intended for real-time monitoring. Indications for use of Cordiana Dx 16 are quantification and reporting of cardiopulmonary function of patients (adults and children of any age from birth upwards) with suspected disease to support the physicians in the diagnosis. Cordiana Dx 16 does not provide automated determination of fiducial points, interpretative statements, or patient diagnosis.

Source page: https://510kreport.com/device/K201060
Methodology: https://510kreport.com/methodology