MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE
Device Facts
| Record ID | K896024 |
|---|---|
| Device Name | MDT/CASTLE MODEL HDX DENTAL X-RAY MACHINE |
| Applicant | Mdt Diagnostic Co. |
| Product Code | EAP · Dental |
| Decision Date | Jan 22, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.1810 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An intraoral source x-ray system is an electrically powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located inside the mouth. This generic type of device may include patient and equipment supports and component parts.
