FDA 510(k) Application Details - K241847

Device Classification Name	More FDA Info for this Device
510(K) Number	K241847
Device Name	Imbio PHA (4.0.0)
Applicant	Imbio, Inc 1015 Glenwood Ave Floor 4 Minneapolis, MN 55405 US Other 510(k) Applications for this Company
Contact	Lauren Keith 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	06/26/2024
Decision Date	08/30/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review