# K162085: i-CAT FLX V series / KaVo 3D eXam+ V series

- Pathway: 510(k) (Traditional)
- Applicant: Imaging Sciences International
- Decided: Nov 10, 2016 after 106 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- 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: 8 generations back to K973642 (1997). 16 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123070: Galileos Family, Sirona Dental Systems GmbH (2013) Summary page 4.
- K133620: Cone Beam 3D and 2D Panoramic Dental Imaging System, Imaging Sciences International (2014) Summary page 4.

## Most influential descendants
- K243337: Dental Cone Beam Computed Tomography System (2025), 1 descendant of its own
- K260662: Dental Cone Beam Computed Tomography System (2026), 0 descendants of its own

## Indications for use
Devices of the i-CAT family consist of an x-ray system that uses a cone beam with a rotational sequence, providing two dimensional images and three dimensional volume reconstructions of the head area, which includes ENT and maxillofacial areas (such as TM Joint studies, mandible & maxilla for implant planning, sinuses, airway), for use in planning and diagnostic support in adult and pediatric care. Devices of the i-CAT family comprise a package of software modules capable of handling 2D and 3D data. This includes 3D reconstruction, storage, retrieval, viewing, and processing of 2D and 3D-image data.

Source page: https://510kreport.com/device/K162085
Methodology: https://510kreport.com/methodology