Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1171](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1171) → SAO — Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

# SAO · Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density

_Radiology · 21 CFR 892.1171 · Class 2_

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

## Overview

- **Product Code:** SAO
- **Device Name:** Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
- **Regulation:** [21 CFR 892.1171](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1171)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)

## Identification

Radiology software for opportunistic evaluation of low bone mineral density. This device is software which opportunistically assesses radiological images to estimate bone mineral density (BMD) intended to assist in a healthcare professional's decision to evaluate patients for possible low BMD within a bone health screening program. The software employs an algorithm that estimates BMD using eligible radiological image data obtained for other clinical purposes.

## Classification Rationale

Class II (special controls). The device is classified as Class II because the probable benefits outweigh the probable risks, and the risks can be mitigated by the use of general controls and the identified special controls.

## Special Controls

In combination with the general controls of the FD&C Act, radiology software for opportunistic evaluation of low bone mineral density is subject to the following special controls:

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K251408](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/SAO/K251408.md) | OsteoSight™ Hip (v1) | Naitive Technologies, Ltd. | Sep 2, 2025 | SESE |
| [DEN230023](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/SAO/DEN230023.md) | Rho | 16 Bit, Inc. | Apr 9, 2024 | DENG |

## Top Applicants

- 16 Bit, Inc. — 1 clearance
- Naitive Technologies, Ltd. — 1 clearance

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

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