# K241029: SpineUs™ System

- Pathway: 510(k) (Traditional)
- Applicant: Verdure Imaging
- Decided: Oct 7, 2024 after 175 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 23 generations back to K935595 (1995). 155 ancestors in all.
No later device cites it as a predicate yet.
0 of 156 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231966: Logiq E10, GE Medical Systems Ultrasound and Primary Care Diagnostics (2023) Summary page 5.

## Indications for use
The SpineUs ™ system is a software-based, tracked, ultrasound imaging system and accessories, intended for diagnostic imaging. It is indicated for diagnostic ultrasound imaging in the following applications: musculoskeletal (conventional, superficial). The system is intended for use by trained chiropractors and radiologists in a hospital or medical clinic. The SpineUs TM system is intended for assisting trained chiropractors and radiologists in acquiring, viewing, and measuring ultrasound images of the spine in both clinic and hospital settings. The SpineUs TM system is intended to be used as an adjunct to conventional imaging method that allows trained chiropractors and radiologists to measure spine-related anatomical components on images (e.g., intervertebral angles and spine curvature). The system also allows the review and management of patient measurement data. Clinical judgment of anatomy and experience are required to properly use the SpineUs TM system. Patient management decisions should not be made based solely on the results of the SpineUs TM computer application. The user shall retain the ultimate responsibility of ascertaining the measurements based on standard practices and clinical judgement.

Source page: https://510kreport.com/device/K241029
Methodology: https://510kreport.com/methodology