FDA 510(k) Application Details - K211645

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K211645
Device Name	System, X-Ray, Tomography, Computed
Applicant	Quantum Surgical SAS ZAC Eureka 1000 rue du Mas de Verchant Montpellier 34000 FR Other 510(k) Applications for this Company
Contact	Lagacherie Elise Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	JAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2021
Decision Date	02/24/2022
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