510(k) · Cardiovascular

Cardio-TriTest v6.5

by Cardio-Phoenix Inc.

Cardio-TriTest v6.5 is an AI-enabled medical device from Cardio-Phoenix Inc. that the U.S. FDA cleared through 510(k) K182790 on December 14, 2018. Its lead review panel is Cardiovascular and its primary product code is DPS (Electrocardiograph).

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

Key facts

Submission numberK182790
Pathway510(k)
Date of final decision
Company (FDA list)Cardio-Phoenix Inc.
Lead review panelCardiovascular
Primary product codeDPS — Electrocardiograph
Applicant (openFDA)Cardio-Phoenix, Inc.
Applicant locationMarkham, CA
Device classClass 2
Regulation number21 CFR 870.2340
Decision codeSESE
Submission typeSpecial

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. Cardio-TriTest v6.5 went through this pathway (K182790).

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 #2 of 7 under that code. Cardio-Phoenix 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.

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