FDA 510(k) Application Details - K223032

Device Classification Name	More FDA Info for this Device
510(K) Number	K223032
Device Name	SIS System (Version 5.6.0)
Applicant	Surgical Information Sciences, Inc. 4602 141st Ln NE Ham Lake, MN 55304 US Other 510(k) Applications for this Company
Contact	Ann Quinlan-Smith 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	09/29/2022
Decision Date	11/21/2022
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