# K190856: SeeFactorCT3

- Pathway: 510(k) (Traditional)
- Applicant: Epica International, Inc.
- Decided: Sep 20, 2019 after 171 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: 1 generation back to K142222 (2015). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142222: NewTom 5G, Qr S.R.L. (2015) Summary page 5.

## Indications for use
SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquires sequences of the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibular joint (TMJ), other areas of human skull and neck with sections of upper cervical spine, and upper and lower extremities for use in diagnostic support. The device displays two and three dimensional images for each examined anatomical region. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

Source page: https://510kreport.com/device/K190856
Methodology: https://510kreport.com/methodology