# K180727: LineUp

- Pathway: 510(k) (Traditional)
- Applicant: Curvebeam, LLC
- Decided: May 11, 2018 after 52 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K113548 (2012). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113548: Pedcat, Curvebeam, LLC (2012) Summary page 5.

## Most influential descendants
- K203187: HiRise (2020), 1 descendant of its own
- K241713: HiRise (1040-230) (2024), 0 descendants of its own

## Indications for use
The LineUP is intended to be used for 3-D imaging of the foot, knee, hand, and elbow regions to visualize and assess the osseous and certain soft tissue structures, including joint spaces, bone angles and fractures. It is also intended to capture 2-D images (standard plain x-ray projections) of the foot, knee, hand, and elbow regions. This modality is anticipated to be applicable to pediatric* cases as well as adults, when appropriate diagnosis of a given condition is considered necessary. Patient parameters: 50 lbs to 400 lbs *2D Imaging not intended for pediatric use

Source page: https://510kreport.com/device/K180727
Methodology: https://510kreport.com/methodology