FDA 510(k) Application Details - K240224

Device Classification Name	More FDA Info for this Device
510(K) Number	K240224
Device Name	Zenition 90
Applicant	Philips Medical Systems Nederlands B.V. Veenpluis 6 Best 5684 PC NL Other 510(k) Applications for this Company
Contact	Rahul Kumar Sinha 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	01/26/2024
Decision Date	05/22/2024
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