FDA 510(k) Application Details - K211876

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K211876
Device Name	System, Image Processing, Radiological
Applicant	Intellijoint Surgical Inc. 809 Wellington Street North , Unit 2 Kitchener N2H 5L6 CA Other 510(k) Applications for this Company
Contact	Katarina Jugovic 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	06/17/2021
Decision Date	11/12/2021
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