FDA 510(k) Application Details - K243218

Device Classification Name	Densitometer, Bone   More FDA Info for this Device
510(K) Number	K243218
Device Name	Densitometer, Bone
Applicant	Medimaps Group SA Chemin du Champ-des-Filles 36 Plan-les-Ouates 1228 CH Other 510(k) Applications for this Company
Contact	Giorgio Zoia Other 510(k) Applications for this Contact
Regulation Number	892.1170   More FDA Info for this Regulation Number
Classification Product Code	KGI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/04/2024
Decision Date	01/17/2025
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