FDA 510(k) Application Details - K244012

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K244012
Device Name	System, Image Processing, Radiological
Applicant	Navier Medical Level 13, Office 1 256 Adelaide Tce Perth 6000 AU Other 510(k) Applications for this Company
Contact	Aastha Chaudhary 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	12/26/2024
Decision Date	06/16/2025
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