# K032355: Orthoralix 9200 Dde, Orthoralix 9200 Dde Plus Ceph, Models 5105 0161WW, 5105 0181WW

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Gendex
- Decided: Sep 25, 2003 after 57 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: 1 (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 and 9200 Plus: named in the summary without a submission number
- (no number) Instrumentarium Orthoceph® OC 100 D Direct Digital Cephalometric Imaging System: named in the summary without a submission number
- (no number) Planmeca DIMAX2 Direct Digital Imaging System: named in the summary without a submission number
- (no number) Sirona Orthophos Plus 13S: named in the summary without a submission number

## Most influential descendants
- K101661: Myray Hyperion (2010), 0 descendants of its own

## Recalls of this device
- Feb 4, 2011 · Not classified · Z-2041-2011: 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

## Indications for use
The Orthoralix 9200 DDE Digital Panoramic and Cephalometric 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/K032355
Methodology: https://510kreport.com/methodology