FDA 510(k) Application Details - K192038

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K192038
Device Name	System, Image Processing, Radiological
Applicant	Covidien LLC. 5920 Longbow Drive Boulder, CO 80301 US Other 510(k) Applications for this Company
Contact	Janna Babson 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	07/30/2019
Decision Date	12/02/2019
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