510(k) · Radiology

Brainomix 360 e-ASPECTS

by Brainomix Limited

Brainomix 360 e-ASPECTS is an AI-enabled medical device from Brainomix Limited that the U.S. FDA cleared through 510(k) K221564 on February 23, 2023. Its lead review panel is Radiology and its primary product code is POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer).

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

Key facts

Submission numberK221564
Pathway510(k)
Date of final decision
Company (FDA list)Brainomix Limited
Lead review panelRadiology
Primary product codePOK — Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Applicant (openFDA)Brainomix Limited
Applicant locationOxford, GB
Device classClass 2
Regulation number21 CFR 892.2060
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. Brainomix 360 e-ASPECTS went through this pathway (K221564).

openFDA lists it as a Class 2 device under 21 CFR 892.2060. Class II devices are moderate risk and are subject to general and special controls.

Product code POK covers 22 devices on the FDA AI list. By decision date, this device is #8 of 22 under that code. Brainomix Limited has 8 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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