← Product Code [KGI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI) · K915535

# FOREARM SOFTWARE FOR LUNAR DPX SERIES BONE DESITOM (K915535)

_Lunar · KGI · Feb 27, 1992 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI/K915535

## Device Facts

- **Applicant:** Lunar
- **Product Code:** [KGI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI.md)
- **Decision Date:** Feb 27, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1170
- **Device Class:** Class 2
- **Review Panel:** Radiology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI/K915535](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI/K915535)

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