510(k) · Cardiovascular

ZEUS System

by iRhythm Technologies, Inc.

ZEUS System is an AI-enabled medical device from iRhythm Technologies, Inc. that the U.S. FDA cleared through 510(k) K222389 on February 15, 2023. Its lead review panel is Cardiovascular and its primary product code is DQK (Computer, Diagnostic, Programmable).

See also FDA-cleared AI cardiovascular devices in 2023, all FDA AI clearances in 2023, top cardiovascular AI devices.

Key facts

Submission numberK222389
Pathway510(k)
Date of final decision
Company (FDA list)iRhythm Technologies, Inc.
Lead review panelCardiovascular
Primary product codeDQK — Computer, Diagnostic, Programmable
Applicant (openFDA)iRhythm Technologies, Inc.
Applicant locationSan Francisco, CA, US
Device classClass 2
Regulation number21 CFR 870.1425
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. ZEUS System went through this pathway (K222389).

openFDA lists it as a Class 2 device under 21 CFR 870.1425. Class II devices are moderate risk and are subject to general and special controls.

Product code DQK covers 28 devices on the FDA AI list. By decision date, this device is #15 of 28 under that code. iRhythm Technologies, Inc. has 6 AI-enabled devices 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.

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