# K110260: Newtom 5G / Newtom 5G Version FP

- Pathway: 510(k) (Special)
- Applicant: Qr S.R.L.
- Decided: Apr 6, 2011 after 68 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: 3 generations back to K003787 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072357: Newtom VG Computed Tomography X-Ray System, Afp Imaging Corp. (2007) Summary page 1.

## Indications for use
The NewTom 5G Computed Tomography X-Ray System is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery. The NewTom 5G accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two-dimensional images and three-dimensional renderings.

Source page: https://510kreport.com/device/K110260
Methodology: https://510kreport.com/methodology