FDA 510(k) Application Details - K171229

Device Classification Name	More FDA Info for this Device
510(K) Number	K171229
Device Name	DELL UP3017 with QUBYX PerfectLum bundle
Applicant	Qubyx Software Technologies Inc. 501 Silverside Road, Suite 105 Wilmington, DE 19809 US Other 510(k) Applications for this Company
Contact	Marc Leppla Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2017
Decision Date	05/26/2017
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