FDA 510(k) Application Details - K243881

Device Classification Name	System, Tomography, Computed, Emission   More FDA Info for this Device
510(K) Number	K243881
Device Name	System, Tomography, Computed, Emission
Applicant	Bracco Diagnostics Inc. 510 Carnegie Center Princeton, NJ 085401 US Other 510(k) Applications for this Company
Contact	Elyssa Murray Other 510(k) Applications for this Contact
Regulation Number	892.1200   More FDA Info for this Regulation Number
Classification Product Code	KPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2024
Decision Date	03/03/2025
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