# K072357: Newtom VG Computed Tomography X-Ray System

- Pathway: 510(k) (Special)
- Applicant: Afp Imaging Corp.
- Decided: Sep 18, 2007 after 27 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003787 (2001). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041137: Newtom 3G QR-DVT 9000, Aperio Services, LLC (2004) Summary page 1.

## Most influential descendants
- K133797: Qmaster-H/Revo (2014), 0 descendants of its own
- K110260: Newtom 5G / Newtom 5G Version FP (2011), 0 descendants of its own

## Indications for use
The NewTom VG 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 VG 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/K072357
Methodology: https://510kreport.com/methodology