# K964659: Orthoralix E/GX-9000 Panoramic X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Dec 23, 1996 after 33 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) PC-1000: named in the summary without a submission number
- (no number) Versa View: named in the summary without a submission number
- (no number) Cranex 2.5 +: named in the summary without a submission number
- (no number) GX-Pan: named in the summary without a submission number
- (no number) Orthoralix SD2/S: named in the summary without a submission number

## Indications for use
The Orthoralix E/GX-9000™ Panoramic Dental X-Ray System is used as an extraoral source of x-rays in dental radiography.

Source page: https://510kreport.com/device/K964659
Methodology: https://510kreport.com/methodology