# K211159: eco-x Series (eco-x, eco-x-s)

- Pathway: 510(k) (Traditional)
- Applicant: Hdx Will Corp.
- Decided: Dec 30, 2021 after 255 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: 9 generations back to K973598 (1997). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160140: DENTRIa    series, Hdx Will Corp. (2016) Summary page 5.
- K093590: Planmeca Promax 3D Max, Planmeca Oy (2010) Summary page 6.

## Indications for use
‘eco-x series (eco-x, eco-x-s)’ is 4 in 1 digital equipment that provides CT, Panoramic, Cephalometric, and Model Scan images by using X-Ray scan. It provides 2D images for diagnosing cranial bone tissue including adult and pediatric teeth, jaw, oral structures and skull. Also, it provides 3D images by reconstructing images acquired by capturing cervical bone and occipital regions. In addition, ‘eco-x series’ is used as diagnosis for general and/or orthodontic treatment, and also is intended to use for ENT (Ear, Nose, and Throat) and dentomaxillofacial diagnosis.

Source page: https://510kreport.com/device/K211159
Methodology: https://510kreport.com/methodology