# K241302: SonoSync

- Pathway: 510(k) (Traditional)
- Applicant: Samsung Medison Co., Ltd.
- Decided: Aug 23, 2024 after 106 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: 9 generations back to K971684 (1997). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212777: Collaboration Live, Philips Ultrasound, Inc. (2021) Summary page 4.

## Indications for use
SonoSync is a software solution for live streaming images acquired through ultrasound systems to healthcare professionals for diagnostic image viewing, remote access, review, consultation, guidance, support and education in real time. It is required to follow the technical and operator requirements in the User Manual. As users of this remote solution, the healthcare professionals take responsibility for ensuring that image quality, display contrast and ambient light conditions meet the generally accepted practices of the ultrasound imaging.

Source page: https://510kreport.com/device/K241302
Methodology: https://510kreport.com/methodology