FDA 510(k) Application Details - K243679

Device Classification Name	More FDA Info for this Device
510(K) Number	K243679
Device Name	MammoScreen« (4)
Applicant	Therapixel 455 Promenade des Anglais Nice 06200 FR Other 510(k) Applications for this Company
Contact	Pierre Fillard Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/29/2024
Decision Date	07/03/2025
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