← Product Code [KGI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI) · K881865

# NORLAND MODEL XR-26 X-RAY BONE DENSITOMETER (K881865)

_Norland Corp. · KGI · Mar 14, 1989 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI/K881865

## Device Facts

- **Applicant:** Norland Corp.
- **Product Code:** [KGI](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI.md)
- **Decision Date:** Mar 14, 1989
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI/K881865](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/KGI/K881865)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com