# K240620: Cube Navigator

- Pathway: 510(k) (Traditional)
- Applicant: Medical Templates AG
- Decided: Mar 25, 2024 after 20 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: 12 generations back to K913770 (1991). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141745: Iqqa-Bodyimaging Software, Edda Technology (2014) Summary page 4.

## Indications for use
Cube Navigator is a non-invasive software intended for planning the needle trajectory of CT-guided, percutaneous punctures using DICOM-images and a Navigation Cube attached to a patient. It is indicated for the planning the needle trajectory of CT-guided, percutaneous punctures for therapeutic and diagnostic purposes. The software's functionality allows to automatically recognize orientation, position and type of the Navigation Cube present in the DICOM-images and to manually define virtual needle trajectories to a physician-identified target through the Navigation Cube. Based on this planning, Cube Navigator provides physician information for such purpose. Cube Navigator can only be used in combination with a Navigation Cube, specifically, either the Access Cube for instruments 10-20G (article number mt-ac-ct-20, Class 1 exempt, product code GDF) or the Puncture Cube for instruments 18-22G (article number mt-pc-ct-25, Class 1 exempt, product code GDF). Cube Navigator is a standalone software that integrates the CE-marked and FDA-cleared diagnostic Medical Imaging Viewer medDream manufactured by Softneta that provides all DICOM-related functionality like displaying and manipulating DICOM-images. The Cube Navigator is intended for interventional radiologists, who perform CT-guided interventions for therapeutic and diagnostic purposes. The intended use environment is the CT control room, which can be in a hospital or a medical office.

Source page: https://510kreport.com/device/K240620
Methodology: https://510kreport.com/methodology