# K242805: Dental Cone-beam Computed Tomography (FinScan F350)

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Finno Medical Technology Co., Ltd.
- Decided: Jan 9, 2025 after 114 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: 14 generations back to K973642 (1997). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213226: RCT700, Ray Co., Ltd. (2021) Summary page 5.

## Indications for use
FinScan F350 is CBCT, panoramic and cephalometric x-ray imaging system. The device is intended to radiographic examination of the dento-maxillofacial and TMJ structure for diagnostic support for adult and pediatric patients. Cephalometric image also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment. The device is to be operated and used by dentists or other legally qualified health care professionals.

Source page: https://510kreport.com/device/K242805
Methodology: https://510kreport.com/methodology