# K991455: Orthoslice OS1000 Series; Panoramic Orthoslice OS 1000: OS1000, OS1000E Panoramic and Cephalometric Orthoslice OS1000C,

- Pathway: 510(k) (Traditional)
- Applicant: Trophy Radiologie
- Decided: Jun 25, 1999 after 60 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The 0S1000 serie is software controlled diagnostic panoramic dental x-ray equipment for producing high quality images of dentition with multiple orbit, TMJ, sinus. Cross section radiography is also possible. Theses models can be applied widely to not only orthodontic, prothesis, oral surgery, implant treatment, but also ortorhinolaryngology, orthodontics. The 0S1000 is a Panoramic and Tomographic unit. The OS1000E is only a Panoramic unit The OS1000C is a Panoramic,Tomographic and Cephalometric unit. The OS1000EC is only a Panoramic and Cephalometric unit

Source page: https://510kreport.com/device/K991455
Methodology: https://510kreport.com/methodology