X-POSURE SYSTEM VERSION 2 RAD
Device Facts
| Record ID | K002500 |
|---|---|
| Device Name | X-POSURE SYSTEM VERSION 2 RAD |
| Applicant | Pronosco A/S |
| Product Code | KGI · Radiology |
| Decision Date | Oct 23, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1170 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
