510(k) Report

Devices descending from K221564

2 later devices reach Brainomix 360 e-ASPECTS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250221StrokeSENS ASPECTS Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+1K243294Brainomix 360 e-ASPECTSBrainomix Limited20250—