FDA 510(k) Application Details - K192629

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K192629
Device Name	System, Image Processing, Radiological
Applicant	Optima Health Solutions International Corp. Unit 303 - 828 W 8th Avenue Vancouver V5Z 1E2 CA Other 510(k) Applications for this Company
Contact	Farhad Ghani 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	09/23/2019
Decision Date	12/21/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review