# K133797: Qmaster-H/Revo

- Pathway: 510(k) (Traditional)
- Applicant: Telesystems Co., Ltd.
- Decided: Sep 4, 2014 after 265 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: 4 generations back to K972312 (1997). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113497: Hyperion, Cefla S.C. Cefla Dental Group (2012) Summary page 5.
- K103711: Orthophos XG 3D / Ceph, Sirona Dental Systems GmbH (2011) Summary page 5.
- K072357: Newtom VG Computed Tomography X-Ray System, Afp Imaging Corp. (2007) Summary page 5.

## Indications for use
QRmaster-H/Revo 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 device accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume, and displaying both 2D images and 3D renderings. This technique is known as cone beam computed tomography, or CBCT. All devices are sold by or on the order of a physician. They are not for use by the general public or over-the-counter.

Source page: https://510kreport.com/device/K133797
Methodology: https://510kreport.com/methodology