FDA 510(k) Application Details - K214062

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K214062
Device Name	System, Tomography, Computed, Emission
Applicant	Radialis Inc. Suite 2300B, 290 Munro Street Thunder Bay P7A 7T1 CA Other 510(k) Applications for this Company
Contact	Michael Waterston Other 510(k) Applications for this Contact
Regulation Number	892.1200   More FDA Info for this Regulation Number
Classification Product Code	KPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2021
Decision Date	02/04/2022
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	Y
Expedited Review