# OsteoDetect

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/osteodetect-qbs>
- Manufacturer: [Imagen Technologies, Inc.](https://devicerts.com/manufacturers/fda-fei-3014661828) (FDA registration: United States)
- Device class: Class II (US FDA)
- FDA product code: QBS

## Overview

*AI-generated summary, 2026-11-10. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

OsteoDetect is a radiological computer assisted detection/diagnosis software for fracture, as listed by the FDA under the product name Radiological Computer Assisted Detection/Diagnosis Software For Fracture. It was authorized under the De Novo grant DEN180005, which was decided on 2018-05-24.

## Registrations and authorizations

- **De Novo** · FDA De Novo · United States · DEN180005 · decision 2018-05-24 · decision DENG · status: Active

## Recalls

No recall on record.

## Identifiers

- De Novo Number: DEN180005 [FDA 510(k)]
- FDA product code: QBS [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.2090 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: DENG [FDA 510(k)]

## Source and citation

- Cite as: OsteoDetect, Imagen Technologies, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/osteodetect-qbs (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-11-10
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/osteodetect-qbs.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/osteodetect-qbs
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.