510(k) · Radiology

Sonix Health

by Ontact Health Co., Ltd

Sonix Health is an AI-enabled medical device from Ontact Health Co., Ltd that the U.S. FDA cleared through 510(k) K240645 on November 27, 2024. Its lead review panel is Radiology and its primary product code is QIH (Automated Radiological Image Processing Software).

See also FDA-cleared AI radiology devices in 2024, all FDA AI clearances in 2024, top radiology AI devices.

Key facts

Submission numberK240645
Pathway510(k)
Date of final decision
Company (FDA list)Ontact Health Co., Ltd
Lead review panelRadiology
Primary product codeQIH — Automated Radiological Image Processing Software
Applicant (openFDA)Ontact Health Co., Ltd.
Applicant locationSeoul, KR
Device classClass 2
Regulation number21 CFR 892.2050
Decision codeSESE
Submission typeTraditional

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

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Sonix Health went through this pathway (K240645).

openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.

Product code QIH covers 305 devices on the FDA AI list. By decision date, this device is #158 of 305 under that code. Ontact Health Co., Ltd has 2 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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