FOCUS
Device Facts
| Record ID | K001729 |
|---|---|
| Device Name | FOCUS |
| Applicant | Instrumentarium Corp. |
| Product Code | EHD · Dental |
| Decision Date | Jul 13, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.1800 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An extraoral source x-ray system is an AC-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 outside the mouth. This generic type of device may include patient and equipment supports and component parts.
