FDA 510(k) Application Details - K222998

Device Classification Name	More FDA Info for this Device
510(K) Number	K222998
Device Name	F3
Applicant	Acrew Imaging, Inc. 38852 Cedar Waxwing Lane Ocean View, DE 19970 US Other 510(k) Applications for this Company
Contact	Craig Hughes Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2022
Decision Date	06/20/2023
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