# K220664: NewTom 7G

- Pathway: 510(k) (Traditional)
- Applicant: Cefla S.C.
- Decided: May 6, 2022 after 60 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
Longest line of descent: 1 generation back to K183448 (2019). 1 ancestor in all.
1 later device descends 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)
- K183448: NewTom 5G XL, Cefla S.C. (2019) Summary page 4.

## Most influential descendants
- K250318: Planmed XFI (2025), 0 descendants of its own

## Indications for use
The NewTom 7G is a computed tomography x-ray imaging system using the cone-beam technology which acquires sequences of images of the head, including ear, nose and throat (ENT), of the dento-maxillofacial complex, teeth, mandible, jaw and temporomandibular joint (TMJ), of the other areas of the human skull and neck with sections of upper cervical spine, of the spine sections, of upper extremities including shoulder, upper arm, forearm, hand, relative joints and of lower extremities including hip, upper leg, lower leg, midfoot, forefoot, relative joints, 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 managed and used by doctors, dentists, radiologists and other legally qualified professionals.

Source page: https://510kreport.com/device/K220664
Methodology: https://510kreport.com/methodology