# K151612: NewTom VGi evo

- Pathway: 510(k) (Traditional)
- Applicant: Qr S.R.L.
- Decided: Mar 31, 2016 after 290 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 K130442 (2013). 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)
- K130442: Newtom Vgi and Newtom 5G, Qr S.R.L. (2013) Summary page 6.

## Indications for use
The NewTom VGi evo is a cone beam computed tomographic x-ray imaging system that acquires sequences of the head including the ENT, dento-maxillofacial complex, temporo-mandibular-joint (TMJ), other areas of human skull and neck with sections of upper cervical spine for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two dimensional views (tomographic sections, pan and ceph projections) displaying both two and three dimensional images. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

Source page: https://510kreport.com/device/K151612
Methodology: https://510kreport.com/methodology