# K072574: Alphard Cone Beam CT, Model X178

- Pathway: 510(k) (Traditional)
- Applicant: Takara Belmont Corp.
- Decided: Oct 18, 2007 after 35 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: 4 generations back to K973598 (1997). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052587: 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf, J. Morita USA, Inc. (2005) Summary page 1.
- K063622: Finecube Dental CT, The Yoshida Dental Mfg. Co., Ltd. (2007) Summary page 1.

## Most influential descendants
- K101181: Bel-Cat (2011), 1 descendant of its own
- K123332: Naomi-CT (2013), 0 descendants of its own

## Indications for use
Alphard Model X1 78 is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. The device is operated and used by physicians, dentists, and x-ray technologists.

Source page: https://510kreport.com/device/K072574
Methodology: https://510kreport.com/methodology