# K050255: Arthoralix 8500, Models 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4

- Pathway: 510(k) (Traditional)
- Applicant: Gendex Dental Systems
- Decided: Mar 17, 2005 after 42 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Gendex Orthoralix 9200: named in the summary without a submission number
- (no number) Planmeca DIMAX2: named in the summary without a submission number
- (no number) Gendex Orthoralix 9200 DDE: named in the summary without a submission number
- (no number) Gendex GX-9000: named in the summary without a submission number

## Most influential descendants
- K091866: Progeny Vantage Panoramic X-Ray System (2009), 0 descendants of its own

## Recalls of this device
- Feb 4, 2011 · Not classified · Z-2040-2011: There is an anomaly in the Orthoralix firmware which can cause a message corruption which will distort the patient image being transferred from the X-Ray system to the PC. This image distortion/corrup
- Dec 21, 2010 · Not classified · Z-1373-2011: The Automatic Exposure Control (AEC) feature located on the control panel of the Orthoralix 8500 Panoramic Dental X-Ray System was functional, but was subsequently disabled in units manufactured start

## Indications for use
The Orthoralix 8500 Panoramic Dental X-Ray System is to be used as an extraoral source of x-rays for imaging of the dento-maxilofacial area.

Source page: https://510kreport.com/device/K050255
Methodology: https://510kreport.com/methodology