FDA 510(k) Application Details - K202212

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K202212
Device Name	System, Image Processing, Radiological
Applicant	Circle Cardiovascular Imaging Inc. Suite 1100-800 5th Ave SW Calgary T2P 3T6 CA Other 510(k) Applications for this Company
Contact	Shirantha Samarappuli Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/06/2020
Decision Date	02/19/2021
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