MODIFIED OSTEOANALYZER (# SPSHA110/220)
Device Facts
| Record ID | K891582 |
|---|---|
| Device Name | MODIFIED OSTEOANALYZER (# SPSHA110/220) |
| Applicant | Osteon, Inc. |
| Product Code | KGI · Radiology |
| Decision Date | Sep 12, 1989 |
| 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.
