FDA 510(k) Application Details - K250800

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K250800
Device Name	System, Image Processing, Radiological
Applicant	Philips DS North America LLC 3630 SW 47th Avenue Gainesville, FL 32608 US Other 510(k) Applications for this Company
Contact	Sagar Pimpalwar 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	03/14/2025
Decision Date	06/05/2025
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