# K051853: Cardiostream Sonoaim

- Pathway: 510(k) (Traditional)
- Applicant: Cardiostream, LLC
- Decided: Aug 22, 2005 after 45 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: 5 generations back to K950279 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041029: Kinetdx, Siemens Medi Cal Solutions, Inc. (2004) Summary page 2.

## Indications for use
The CardioStream SonoAim is intended for capturing, transporting, and reporting patient cardiac study data.

Source page: https://510kreport.com/device/K051853
Methodology: https://510kreport.com/methodology