# K183448: NewTom 5G XL

- Pathway: 510(k) (Traditional)
- Applicant: Cefla S.C.
- Decided: Mar 8, 2019 after 86 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K142222: NewTom 5G, Qr S.R.L. (2015). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K220664: NewTom 7G (2022), 1 descendant of its own
- K250318: Planmed XFI (2025), 0 descendants of its own

## Indications for use
The NewTom 5G XL is cone beam computed tomography x-ray imaging system that acquires sequences of images of the head, including ear, nose and throat (ENT), of dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibular joint (TMJ), other areas of the human skull and neck with sections of upper cervical spine and of the upper and lower extremities for use in diagnostic support. The device accomplishes this task by reconstructing a 3D 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.

Source page: https://510kreport.com/device/K183448
Methodology: https://510kreport.com/methodology