FDA 510(k) Application Details - K221248

Device Classification Name	More FDA Info for this Device
510(K) Number	K221248
Device Name	Rapid LVO
Applicant	iSchemaView Inc. 1120 Washington Ave., Ste 200 Golden, CO 80401 US Other 510(k) Applications for this Company
Contact	James Rosa Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2022
Decision Date	05/31/2022
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