510(k) · Neurology

Sense System with IBT Electrodes

by Infinite Biomedical Technologies, LLC

Sense System with IBT Electrodes is an AI-enabled medical device from Infinite Biomedical Technologies, LLC that the U.S. FDA cleared through 510(k) K182112 on October 5, 2018. Its lead review panel is Neurology and its primary product code is GXY (Electrode, Cutaneous).

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

Key facts

Submission numberK182112
Pathway510(k)
Date of final decision
Company (FDA list)Infinite Biomedical Technologies, LLC
Lead review panelNeurology
Primary product codeGXY — Electrode, Cutaneous
Applicant (openFDA)Infinite Biomedical Technologies, LLC
Applicant locationBaltimore, MD, US
Device classClass 2
Regulation number21 CFR 882.1320
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. Sense System with IBT Electrodes went through this pathway (K182112).

openFDA lists it as a Class 2 device under 21 CFR 882.1320. Class II devices are moderate risk and are subject to general and special controls.

Product code GXY covers 5 devices on the FDA AI list. By decision date, this device is #1 of 5 under that code. Infinite Biomedical Technologies, LLC has 1 AI-enabled device on the list, and the Neurology panel accounts for 73 in total.

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

Similar devices (product code GXY)