# K191719: X-MIND Trium

- Pathway: 510(k) (Traditional)
- Applicant: De Gotzen S.R.L.
- Decided: Feb 20, 2020 after 239 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K123381 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160166: X-MIND trium, De Gotzen S.R.L. (2016) Summary page 6.

## Indications for use
X-MIND trium is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in: - producing panoramic X-ray images for diagnostic examination of dentition (teeth), jaws and oral structures; - producing radiographs of maxillofacial region and parts of the skull for cephalometric examination, if equipped with CEPH arm; - producing radiographs of hands and wrists for carpus examination, if equipped with CEPH arm; - producing tomographic images of the oral and maxillofacial region, for diagnostic examination of dentition (teeth), jaws, oral structures and some cranial bones, if equipped with CBCT option. From a clinical point of view, X-MIND trium can be applied for the following medical indications: • Generic dentistry • Dental implantology • Dental surgery • Maxillo-facial surgery • Cephalometric analysis • Carpus radiology The target patient population includes adults and pediatric patients from 5 years old [~21 kg (46 lb); 113 cm (44.5 in) standing height]; anyway the sustainability to X-ray exposure must be evaluated by surgeons, dentists and qualified and authorized physicians.

Source page: https://510kreport.com/device/K191719
Methodology: https://510kreport.com/methodology