# K260234: MSK Go

- Pathway: 510(k) (Traditional)
- Applicant: Smart Alfa Teknoloji San. Ve Tic. A.S.
- Decided: May 21, 2026 after 115 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 16 generations back to K935595 (1995). 113 ancestors in all.
No later device cites it as a predicate yet.
0 of 114 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222406: Clarius AI, Clarius Mobile Health Corp. (2023) Summary page 5.

## Indications for use
MSK Go is indicated to assist healthcare professionals trained and qualified in MSK (musculoskeletal) ultrasound by highlighting anatomical structures on musculoskeletal ultrasound images acquired using the compatible ultrasound systems. MSK Go is indicated for use in adult patients 18 years of age or older. MSK Go is not intended for diagnostic purposes, or to replace clinical decision-making. The following joint regions are supported: Shoulder,Elbow, Hand and Wrist, Knee, Foot and Ankle

Source page: https://510kreport.com/device/K260234
Methodology: https://510kreport.com/methodology