FDA 510(k) Application Details - K241620

Device Classification Name	Analyzer,Medical Image   More FDA Info for this Device
510(K) Number	K241620
Device Name	Analyzer,Medical Image
Applicant	Gleamer SAS 47bis rue des Vinaigriers Paris 75010 FR Other 510(k) Applications for this Company
Contact	Antoine Tournier Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MYN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/05/2024
Decision Date	02/27/2025
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