# K241713: HiRise (1040-230)

- Pathway: 510(k) (Special)
- Applicant: Curvebeam, LLC
- Decided: Jul 12, 2024 after 28 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: 3 generations back to K113548 (2012). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203187: HiRise, Curvebeam, LLC (2020) Summary page 5.

## 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/K241713
Methodology: https://510kreport.com/methodology