MODEL PDEXA BONE DENSITOMETER
Device Facts
| Record ID | K931996 |
|---|---|
| Device Name | MODEL PDEXA BONE DENSITOMETER |
| Applicant | Norland Corp. |
| Product Code | KGI · Radiology |
| Decision Date | Feb 1, 1995 |
| 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.
