FDA 510(k) Application Details - K153593

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K153593
Device Name	System, Image Processing, Radiological
Applicant	PICOFEMTO LLC 228 EAST 45TH STREET NEW YORK, NY 10017 US Other 510(k) Applications for this Company
Contact	Jessica Phillips 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	12/16/2015
Decision Date	02/17/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review