510(k) · Cardiovascular

FibriCheck

by Qompium nv

FibriCheck is an AI-enabled medical device from Qompium nv that the U.S. FDA cleared through 510(k) K173872 on September 28, 2018. Its lead review panel is Cardiovascular and its primary product code is DXH (Transmitters And Receivers, Electrocardiograph, Telephone).

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

Key facts

Submission numberK173872
Pathway510(k)
Date of final decision
Company (FDA list)Qompium nv
Lead review panelCardiovascular
Primary product codeDXH — Transmitters And Receivers, Electrocardiograph, Telephone
Applicant (openFDA)Qompium NV
Applicant locationHasselt, BE
Device classClass 2
Regulation number21 CFR 870.2920
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. FibriCheck went through this pathway (K173872).

openFDA lists it as a Class 2 device under 21 CFR 870.2920. Class II devices are moderate risk and are subject to general and special controls.

Product code DXH covers 6 devices on the FDA AI list. By decision date, this device is #1 of 6 under that code. Qompium nv has 1 AI-enabled device on the list, and the Cardiovascular panel accounts for 154 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 DXH)