# K181962: CubeVue

- Pathway: 510(k) (Traditional)
- Applicant: Curvebeam, LLC
- Decided: Aug 7, 2018 after 15 days
- Product code: LLZ (System, Image Processing, Radiological)
- 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: 8 generations back to K942120 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101342: Osirix MD, Pixmeo Sarl (2010) Summary page 4.

## Indications for use
CubeVue serves as an accessory to Cone Beam CT extremity imaging devices with the intended use to retrieve, display, and distribute 2D and 3D volumetric image data. The image displaying component allows users to manipulate the images to aid in diagnosis and treatment planning, including rotating and navigating through 3D renderings and 2D MPR slices, adjusting display settings, and making measurements. It is the User's responsibility to ensure monitor quality and ambient light conditions are consistent with the clinical application.

Source page: https://510kreport.com/device/K181962
Methodology: https://510kreport.com/methodology