FDA 510(k) Application Details - K162314

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K162314
Device Name	System, X-Ray, Tomography, Computed
Applicant	IMACTIS, SAS 5 AVENUE DU GRAND SABLON LA TRONCHE 38700 FR Other 510(k) Applications for this Company
Contact	MADY BATAILH 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	08/18/2016
Decision Date	04/24/2018
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