FDA 510(k) Application Details - K250282

Device Classification Name	More FDA Info for this Device
510(K) Number	K250282
Device Name	Persona C HR
Applicant	A.T.S. Applicazione Tecnologie Speciali s.r.l. Via Alessandro Volta, 10 Torre de' Roveri 24060 IT Other 510(k) Applications for this Company
Contact	Francesca Pedretti 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	01/31/2025
Decision Date	04/30/2025
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