510(k) · Cardiovascular

RX-1 Rhythm Express Remote Cardiac Monitoring System

by VivaQuant Inc.

RX-1 Rhythm Express Remote Cardiac Monitoring System is an AI-enabled medical device from VivaQuant Inc. that the U.S. FDA cleared through 510(k) K183704 on February 16, 2019. 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 2019, all FDA AI clearances in 2019, top cardiovascular AI devices.

Key facts

Submission numberK183704
Pathway510(k)
Date of final decision
Company (FDA list)VivaQuant Inc.
Lead review panelCardiovascular
Primary product codeDXH — Transmitters And Receivers, Electrocardiograph, Telephone
Applicant (openFDA)VivaQuant, Inc.
Applicant locationSt. Paul, MN, US
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. RX-1 Rhythm Express Remote Cardiac Monitoring System went through this pathway (K183704).

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 #3 of 6 under that code. VivaQuant Inc. has 2 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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