510(k) · Radiology

1CMR Pro

by Mycardium AI Limited

1CMR Pro is an AI-enabled medical device from Mycardium AI Limited that the U.S. FDA cleared through 510(k) K242062 on November 15, 2024. Its lead review panel is Radiology and its primary product code is LLZ (System, Image Processing, Radiological).

See also FDA-cleared AI radiology devices in 2024, all FDA AI clearances in 2024, top radiology AI devices.

Key facts

Submission numberK242062
Pathway510(k)
Date of final decision
Company (FDA list)Mycardium AI Limited
Lead review panelRadiology
Primary product codeLLZ — System, Image Processing, Radiological
Applicant (openFDA)Mycardium AI Limited
Applicant locationLiverpool, GB
Device classClass 2
Regulation number21 CFR 892.2050
Decision codeSESE
Submission typeAbbreviated

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. 1CMR Pro went through this pathway (K242062).

openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.

Product code LLZ covers 161 devices on the FDA AI list. By decision date, this device is #147 of 161 under that code. Mycardium AI Limited has 2 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 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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