AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER
Device Facts
| Record ID | K950667 |
|---|---|
| Device Name | AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER |
| Applicant | Chicago X-Ray Systems, Inc. |
| Product Code | EAP · Dental |
| Decision Date | Apr 6, 1995 |
| 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.
