# K190357: Star-X, Intraoral X-ray System

- Pathway: 510(k) (Traditional)
- Applicant: Hdx Will Corp.
- Decided: Mar 15, 2019 after 28 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- 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: 2 generations back to K874238 (1987). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970975: Prostyle Intra, Planmeca Oy (1997) Summary page 5.
- K042260: Phot-X II, Model 303, Takara Belmont USA, Inc. (2004) Summary page 5.

## Indications for use
Star-X is intra-oral X-ray system for dental diagnosis that can radiate X-ray images by irradiating X-rays generated by high voltage to an anode in an X-ray tube and reacting with the receptor (film, sensor). Star-X is a dental X-ray equipment (extra-oral source system) intended for use by qualified dentist or dental technician for both adult and pediatric patient for producing diagnostic dental radiographs for treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.

Source page: https://510kreport.com/device/K190357
Methodology: https://510kreport.com/methodology