FDA 510(k) Application Details - K243447

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K243447
Device Name	System, Image Processing, Radiological
Applicant	Navbit Pty Ltd Suite 201, National Innnovation Centre, 4 Cornwallis Street, South Eveleigh South Eveleigh 2015 AU Other 510(k) Applications for this Company
Contact	David Thomson 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	11/07/2024
Decision Date	12/05/2024
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	Y
Expedited Review