# K130442: Newtom Vgi and Newtom 5G

- Pathway: 510(k) (Traditional)
- Applicant: Qr S.R.L.
- Decided: Jul 3, 2013 after 132 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K151612: NewTom VGi evo (2016), 0 descendants of its own

## Indications for use
NewTom VGi is a cone beam computed tomography x-ray imaging system that acquires a 360 degree rotational 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 of this volume, displaying both two and three dimensional images. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals NewTom 5G is a cone beam computed tomography x-ray imaging system that acquires a 360 degree rotational sequences of the head including the ENT, dento-maxillofacial complex, temporo-mandibular-joint (TMVJ), 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 of this volume, displaying both two and three dimensional images. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals. NewTom 5G is especially designed for: - dento-maxillo-facial complex imaging; - teeth, mandible and jaw imaging for implant planning; - temporal-mandibular joint (TMJ) imaging; - ear, nose and throat (ENT) analysis; - sections of upper cervical-spine imaging;

Source page: https://510kreport.com/device/K130442
Methodology: https://510kreport.com/methodology