FDA 510(k) Application Details - K241819

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K241819
Device Name	System, Image Processing, Radiological
Applicant	Cyncronus LLC 3719 221st Pl SE Bothell, WA 98021 US Other 510(k) Applications for this Company
Contact	Rohit Madan 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	06/24/2024
Decision Date	01/23/2025
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	Y
Expedited Review