Class Class II
Brainomix 360 e-ASPECTS (K221564)
Description
Brainomix 360 e-ASPECTS by Brainomix Limited, an FDA 510(k) cleared radiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221564
Clearance Date2023-02-23
Clearance TypeTraditional
Product CodePOK
Regulation Number892.2060
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221564
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Brainomix 360 e-ASPECTS (K221564) cites 1 predicate device and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200760 | Rapid ASPECTS | Ischemaview, Inc. | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250221 | StrokeSENS ASPECTS Software Application | Circle Cardiovascular Imaging, Inc. | 2025 |
| K243294 | Brainomix 360 e-ASPECTS | Brainomix Limited | 2025 |
Trace the full predicate network for K221564
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.