510(k) · Cardiovascular

physIQ Heart Rhythm and Respiratory Module

by physIQ, Inc

physIQ Heart Rhythm and Respiratory Module is an AI-enabled medical device from physIQ, Inc that the U.S. FDA cleared through 510(k) K183322 on July 10, 2019. Its lead review panel is Cardiovascular and its primary product code is DPS (Electrocardiograph).

See also FDA-cleared AI cardiovascular devices in 2019, all FDA AI clearances in 2019, top cardiovascular AI devices.

Key facts

Submission numberK183322
Pathway510(k)
Date of final decision
Company (FDA list)physIQ, Inc
Lead review panelCardiovascular
Primary product codeDPS — Electrocardiograph
Applicant (openFDA)Physiq, Inc.
Applicant locationNaperville, IL, US
Device classClass 2
Regulation number21 CFR 870.2340
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. physIQ Heart Rhythm and Respiratory Module went through this pathway (K183322).

openFDA lists it as a Class 2 device under 21 CFR 870.2340. Class II devices are moderate risk and are subject to general and special controls.

Product code DPS covers 7 devices on the FDA AI list. By decision date, this device is #3 of 7 under that code. physIQ, Inc 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 DPS)