De Novo · Radiology

OsteoDetect

by Imagen Technologies, Inc.

OsteoDetect is an AI-enabled medical device from Imagen Technologies, Inc. that the U.S. FDA granted through De Novo DEN180005 on May 24, 2018. Its lead review panel is Radiology and its primary product code is QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture).

See also FDA-cleared AI radiology devices in 2018, all FDA AI clearances in 2018, top radiology AI devices.

Key facts

Submission numberDEN180005
PathwayDe Novo
Date of final decision
Company (FDA list)Imagen Technologies, Inc.
Lead review panelRadiology
Primary product codeQBS — Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Applicant (openFDA)Imagen Technologies, Inc.
Applicant locationNew York, NY, US
Device classClass 2
Regulation number21 CFR 892.2090
Decision codeDENG
Submission typeDirect

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. OsteoDetect went through this pathway (DEN180005).

openFDA lists it as a Class 2 device under 21 CFR 892.2090. Class II devices are moderate risk and are subject to general and special controls.

Product code QBS covers 10 devices on the FDA AI list. By decision date, this device is #1 of 10 under that code. Imagen Technologies, Inc. has 6 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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