# K240855: Dental Cone-beam Computed Tomography

- Pathway: 510(k) (Special)
- Applicant: Yian Medical Technology (Haining) Co., Ltd.
- Decided: Apr 25, 2024 after 28 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: 5 generations back to K190320 (2019). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232710: Dental Cone-beam Computed Tomography, Yian Medical Technology (Haining) Co., Ltd. (2024) Summary page 5.

## Indications for use
KP-View 3D is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.

Source page: https://510kreport.com/device/K240855
Methodology: https://510kreport.com/methodology