FDA 510(k) Application Details - K150306

Device Classification Name	System, X-Ray, Fluoroscopic, Image-Intensified   More FDA Info for this Device
510(K) Number	K150306
Device Name	System, X-Ray, Fluoroscopic, Image-Intensified
Applicant	STEPHANIX RADIOLOGICAL SOLUTIONS RUE JEAN MOULIN ZI DU BAYOU LA RICAMARIE 42150 FR Other 510(k) Applications for this Company
Contact	SANDIE PERRET Other 510(k) Applications for this Contact
Regulation Number	892.1650   More FDA Info for this Regulation Number
Classification Product Code	JAA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/09/2015
Decision Date	10/10/2015
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