PRODIGY LATERAL VIEW SOFTWARE
Device Facts
| Record ID | K000826 |
|---|---|
| Device Name | PRODIGY LATERAL VIEW SOFTWARE |
| Applicant | Lunar Corp. |
| Product Code | KGI · Radiology |
| Decision Date | Apr 14, 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.