# K240736: SMART Bun-Yo-Matic X-Ray

- Pathway: 510(k) (Traditional)
- Applicant: Disior, Ltd.
- Decided: Jul 2, 2024 after 106 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: 7 generations back to K924630 (1993). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223757: Bonelogic, Disior, Ltd. (2023) Summary page 6.

## Indications for use
SMART Bun-Yo-Matic X-Ray software is to be used by orthopaedic healthcare professionals for diagnosis and surgical planning in a hospital or clinic environment. The medical imaging type intended to be used as the input of the software is X-ray. The SMART Bun-Yo-Matic X-Ray software provides: * Visualization report of the three-dimensional mathematical models of the anatomical structures of the foot and ankle and three-dimensional models of orthopaedic fixation devices, * Measurement templates containing radiographic measures of foot and ankle, * Surgical planning application for visualization of foot and ankle anatomical three-dimensional structures, radiographic measures, and surgical instrument parameters. The visualization report containing the measurements can be used for the diagnosis of orthopaedic healthcare conditions. The surgical planning application containing the visualizations of the measurements in the context of three-dimensional structural models, orthopaedic fixation device models and surgical instrument parameters can be used for the planning of treatments and operations to correct orthopaedic healthcare conditions of foot and ankle.

Source page: https://510kreport.com/device/K240736
Methodology: https://510kreport.com/methodology