FDA 510(k) Application Details - K240036

Device Classification Name	More FDA Info for this Device
510(K) Number	K240036
Device Name	PIUR tUS Infinity
Applicant	PIUR Imaging GmbH Hamburgerstr. 11/Top 7 Vienna 1050 AT Other 510(k) Applications for this Company
Contact	Milos Stojanovic 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	01/05/2024
Decision Date	09/20/2024
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