# K171012: Veraview X800

- Pathway: 510(k) (Traditional)
- Applicant: J. Morita USA, Inc.
- Decided: Dec 19, 2017 after 259 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: 8 generations back to K973598 (1997). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133544: OP300, Palodex Group OY (2014) Summary page 7.

## Most influential descendants
- K201378: 3D Accuitomo 150N (2021), 0 descendants of its own

## Indications for use
The Veraview X800 is intended to be used for panoramic tomography including linear tomography and scanogram, cephalometric radiography, and cone beam computed tomography. The Veraview X800 is an extraoral source X-ray unit that is used for dental and head radiographic examination and diagnosis of teeth, jaw, oral structure, temporomandibular joint, skull including the dento-maxillofacial areas, and hand for maturity assessment, by exposing an X-ray image receptor to ionizing radiation. The device uses a cone shaped X-ray beam projected onto a flat panel detector, and the examined volume image is reconstructed to be viewed in 2D or 3D viewing stations. The device is to be operated and used by dentists and other legally qualified professionals for pediatric and adult patients.

Source page: https://510kreport.com/device/K171012
Methodology: https://510kreport.com/methodology