FDA 510(k) Application Details - K232420

Device Classification Name	More FDA Info for this Device
510(K) Number	K232420
Device Name	Zenition 30
Applicant	Philips Medical Systems Nederland BV Veenpluis 6 Best 5684PC NL Other 510(k) Applications for this Company
Contact	Gyanendra Mani Tripathi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/2023
Decision Date	02/16/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review