# K042260: Phot-X II, Model 303

- Pathway: 510(k) (Traditional)
- Applicant: Takara Belmont USA, Inc.
- Decided: Sep 7, 2004 after 15 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: 1 generation back to K874238 (1987). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874238: Model 2001 CP, Photon I, Dental, Intraoral X-Ray, Belmont Equipment Corp. (1987) Summary page 1.
- K960819: Heliodent DS, Pelton & Crane Co. (1996) Summary page 1.
- K970975: Prostyle Intra, Planmeca Oy (1997) Summary page 1.

## Most influential descendants
- K190357: Star-X, Intraoral X-ray System (2019), 0 descendants of its own
- K141293: Phot-X Iis Model 505 (2014), 0 descendants of its own

## Indications for use
PHOT-X II MODEL 303 is a extraoral source dental radiographic x-ray unit. This unit works as a diagnostic purpose x-ray source for human teeth with the resultant image recorded on intraoral dental x-ray film or image receptor. The design, function and positioning of the x-ray unit is similar to most all other x-ray machines manufactured for this specific purpose over the past thirty years.

Source page: https://510kreport.com/device/K042260
Methodology: https://510kreport.com/methodology