# K141293: Phot-X Iis Model 505

- Pathway: 510(k) (Traditional)
- Applicant: Takara Belmont Corporation
- Decided: Sep 3, 2014 after 107 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: 3 generations back to K935046 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042260: Phot-X II, Model 303, Takara Belmont USA, Inc. (2004) Summary page 4.
- K043092: Preva, 76IN Arm, 66IN Arm, 56IN Arm, Models P7017, P7016, P7015, Progeny, Inc. (2004) Summary page 4.
- K083344: Heliodent Plus, Sirona Dental Systems GmbH (2008) Summary page 4.

## Indications for use
PHOT-X IIs Model 505 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.

Source page: https://510kreport.com/device/K141293
Methodology: https://510kreport.com/methodology