# K033248: Hitachi CB Mercuray Dental Cone-Beam X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Oct 20, 2003 after 13 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: 1 generation back to K003787 (2001). 1 ancestor in all.
18 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003787: Newtom QR-DVT 9000, Aperio Services, LLC (2001)

## Most influential descendants
- K060892: Galileos (2006), 17 descendants of its own
- K123070: Galileos Family (2013), 13 descendants of its own
- K103711: Orthophos XG 3D / Ceph (2011), 7 descendants of its own
- K133620: Cone Beam 3D and 2D Panoramic Dental Imaging System (2014), 6 descendants of its own
- K150217: Orthophos SL (2015), 5 descendants of its own

## Indications for use
The Hitachi CB MercuRay system is an x-ray imaging device that uses a cone beam with a 360° rotational sequence, providing two-dimensional images and three-dimensional volume reconstructions. The system specifically images the head and neck areas, which includes ENT and dentomaxillofacial areas, for use in planning and diagnostic support.

Source page: https://510kreport.com/device/K033248
Methodology: https://510kreport.com/methodology