510(k) · Cardiovascular

HeartFlow Analysis

by HeartFlow, Inc.

HeartFlow Analysis is an AI-enabled medical device from HeartFlow, Inc. that the U.S. FDA cleared through 510(k) K213857 on October 14, 2022. Its lead review panel is Cardiovascular and its primary product code is PJA (Coronary Vascular Physiologic Simulation Software).

See also FDA-cleared AI cardiovascular devices in 2022, all FDA AI clearances in 2022, top cardiovascular AI devices.

Key facts

Submission numberK213857
Pathway510(k)
Date of final decision
Company (FDA list)HeartFlow, Inc.
Lead review panelCardiovascular
Primary product codePJA — Coronary Vascular Physiologic Simulation Software
Applicant (openFDA)HeartFlow, Inc.
Applicant locationRedwood City, CA, US
Device classClass 2
Regulation number21 CFR 870.1415
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. HeartFlow Analysis went through this pathway (K213857).

openFDA lists it as a Class 2 device under 21 CFR 870.1415. Class II devices are moderate risk and are subject to general and special controls.

Product code PJA covers 8 devices on the FDA AI list. By decision date, this device is #7 of 8 under that code. HeartFlow, Inc. has 7 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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