FDA 510(k) Application Details - K193523

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K193523
Device Name	System, Image Processing, Radiological
Applicant	Arthrex Inc. 1370 Creekside Blvd Naples, FL 34108 US Other 510(k) Applications for this Company
Contact	Heli F Chambi Infantas 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	12/19/2019
Decision Date	04/30/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review