FDA 510(k) Application Details - K241659

Device Classification Name	More FDA Info for this Device
510(K) Number	K241659
Device Name	Ultrasound Workspace (UWS 6.0)
Applicant	Philips Ultrasound LLC 22100 Bothell Everett Hwy Bothell, WA 98021 US Other 510(k) Applications for this Company
Contact	Petra Galgoczy Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2024
Decision Date	02/10/2025
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