FDA 510(k) Application Details - K153705

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K153705
Device Name	System, Image Processing, Radiological
Applicant	3DSYSTEMS, SIMBIONIX PRODUCTS BEIT GOLAN CORNER OF GOLAN AND HANEGEV ST. AIRPORT CITY 70151 IL Other 510(k) Applications for this Company
Contact	KIM TORLUEMKE 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	12/23/2015
Decision Date	09/02/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review