FDA 510(k) Application Details - K201465

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K201465
Device Name	System, Image Processing, Radiological
Applicant	Surgical Theater, Inc. 781 Beta Drive Mayfield Village, OH 44143 US Other 510(k) Applications for this Company
Contact	Kevin Murrock 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	06/02/2020
Decision Date	07/17/2020
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