FDA 510(k) Application Details - K230913

Device Classification Name	More FDA Info for this Device
510(K) Number	K230913
Device Name	ANDI
Applicant	Imeka Solutions, Inc. 195, Belvedere Nord #201 Sherbrooke J1H 4A7 CA Other 510(k) Applications for this Company
Contact	Valerie Lacroix 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	03/31/2023
Decision Date	07/25/2023
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