FDA 510(k) Application Details - K242411

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K242411
Device Name	System, X-Ray, Tomography, Computed
Applicant	Brainomix Limited First Floor, Seacourt Tower West Way Oxford OX2 0JJ GB Other 510(k) Applications for this Company
Contact	Thais Sala Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	JAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/14/2024
Decision Date	02/19/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review