# K222406: Clarius AI

- Pathway: 510(k) (Traditional)
- Applicant: Clarius Mobile Health Corp.
- Decided: Jan 23, 2023 after 167 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: 15 generations back to K935595 (1995). 112 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200232: LVivo Software Application, Dia Imaging Analysis, Ltd. (2020) Summary page 4.

## Most influential descendants
- K260192: DIANA (2026), 0 descendants of its own
- K260234: MSK Go (2026), 0 descendants of its own
- K250226: Clarius Median Nerve AI (2025), 0 descendants of its own

## Indications for use
Clarius AI is intended to semi-automatically place calipers for non-invasive measurements of musculoskeletal structures (e.g., Achilles’ tendon, plantar fascia, patellar tendon) on ultrasound data acquired by the Clarius Ultrasound Scanner (i.e., L7 and L15). The user shall be a healthcare professional trained and qualified in MSK (musculoskeletal) ultrasound. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgment.

Source page: https://510kreport.com/device/K222406
Methodology: https://510kreport.com/methodology