# K121800: Point 500 HD POINT500C HD

- Pathway: 510(k) (Traditional)
- Applicant: Pointnix Co., Ltd.
- Decided: Jan 24, 2013 after 219 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: 7 generations back to K973598 (1997). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111231: Panoura 18S, The Yoshida Dental Mfg. Co., Ltd. (2011) Summary page 1.

## Indications for use
Point 500 HO/SOOC HD which is the dental panoramic/panoramic and cephalometric device is intended to produce diagnostic quality radiographic images by acquiring digital 2D X-ray images. The cephalometric system produces cephalomertric radiographic images that maybe used in orthodontic diagnosis procedures.

Source page: https://510kreport.com/device/K121800
Methodology: https://510kreport.com/methodology