FDA 510(k) Application Details - K243863

Device Classification Name	More FDA Info for this Device
510(K) Number	K243863
Device Name	OpulusÖ Lymphoma Precision
Applicant	Roche Molecular Systems, Inc. 2881 Scott Blvd Santa Clara, CA 95050 US Other 510(k) Applications for this Company
Contact	Aarti Shukla Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/17/2024
Decision Date	05/30/2025
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