# K203187: HiRise

- Pathway: 510(k) (Traditional)
- Applicant: Curvebeam, LLC
- Decided: Nov 18, 2020 after 22 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: 2 generations back to K113548 (2012). 2 ancestors in all.
1 later device descends 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)
- K180727: LineUp, Curvebeam, LLC (2018) Summary page 5.

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

## Indications for use
The HiRise is intended to be used for 3-D imaging of the upper and the lower extremities and pelvis of adult and pediatric patients weighing from 40 to 450 lbs. The device is to be operated in a professional healthcare environment by qualified health care professionals only.

Source page: https://510kreport.com/device/K203187
Methodology: https://510kreport.com/methodology