FDA 510(k) Application Details - K222987

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K222987
Device Name	System, Image Processing, Radiological
Applicant	Akunah PTY LTD 131 Warriewood St Queensland 4151 AU Other 510(k) Applications for this Company
Contact	Shanthan Pather 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	09/28/2022
Decision Date	05/10/2023
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