FDA 510(k) Application Details - K241765

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K241765
Device Name	System, Image Processing, Radiological
Applicant	DOSIsoft SA 45/47 Avenue Carnot Cachan 94230 FR Other 510(k) Applications for this Company
Contact	Marc Uszynski Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2024
Decision Date	03/14/2025
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