FDA 510(k) Application Details - K211431

Device Classification Name	More FDA Info for this Device
510(K) Number	K211431
Device Name	breastscape v1.0
Applicant	Olea Medical 93 Avenue des Sorbiers, ZI ATHELIA IV La Ciotat 13600 FR Other 510(k) Applications for this Company
Contact	Nathalie Palumbo Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/07/2021
Decision Date	08/02/2021
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