FDA 510(k) Application Details - K103659

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K103659
Device Name	X-Ray, Tomography, Computed, Dental
Applicant	TROPHY 4 RUE F. PELLOUTIER CROISSY BEAUBOURG MARNE LA VALLEE CEDEX 2 77437 FR Other 510(k) Applications for this Company
Contact	MARIE-PIERRE LABAT-CAMY Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	OAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2010
Decision Date	08/18/2011
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