FDA 510(k) Application Details - K170540

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K170540
Device Name	System, Image Processing, Radiological
Applicant	Densitas, Inc. 1344 Summer Street, Suite 311.2 Halifax B3H 0A8 CA Other 510(k) Applications for this Company
Contact	Mo Abdolell 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	02/23/2017
Decision Date	02/23/2018
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