Devices · Brainomix Limited

Brainomix 360 e-ASPECTS

Brainomix Limited is listed for Brainomix 360 e-ASPECTS (K221564). The FDA list gives February 23, 2023 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code POK as “Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer”: Assist users in characterizing lesions identified on acquired medical images openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K221564

Official FDA database record

Date of final decision

February 23, 2023

Company on the FDA list

Brainomix Limited

Lead panel

Radiology

Primary product code

POK

openFDA device name for the code

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

Device class

2

Regulation number

892.2060

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary