# K232710: Dental Cone-beam Computed Tomography

- Pathway: 510(k) (Traditional)
- Applicant: Yian Medical Technology (Haining) Co., Ltd.
- Decided: Jan 9, 2024 after 126 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: 4 generations back to K190320 (2019). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221525: PreXion3D Explorer PRO, Prexion Corporation (2022) Summary page 4.

## Most influential descendants
- K251642: Dental CBCT X-ray System (2025), 0 descendants of its own
- K240855: Dental Cone-beam Computed Tomography (2024), 0 descendants of its own

## Indications for use
Dental Cone-beam Computed Tomography (Model:iDT901X1) 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/K232710
Methodology: https://510kreport.com/methodology