FDA 510(k) Application Details - K221230

Device Classification Name	More FDA Info for this Device
510(K) Number	K221230
Device Name	TRON
Applicant	Xoran Technologies LLC 5210 S. State Rd. Ann Arbor, MI 48108 US Other 510(k) Applications for this Company
Contact	Mark McGarrow 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	04/29/2022
Decision Date	07/28/2022
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