FDA 510(k) Application Details - K240822

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K240822
Device Name	System, Image Processing, Radiological
Applicant	Philips Medical Systems Technologies 2 Hapnina Street, P.O. Box 46 Raanana Central 4321538 IL Other 510(k) Applications for this Company
Contact	Shlomit Brandis Kepler 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	03/25/2024
Decision Date	04/24/2024
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