FDA 510(k) Application Details - K203518

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K203518
Device Name	System, Image Processing, Radiological
Applicant	Omniscient Neurotechnology Pty Ltd (o8t) Level 10, 580 George Street Sydney 2000 AU Other 510(k) Applications for this Company
Contact	Arie Henkin 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	12/01/2020
Decision Date	03/09/2021
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