FDA 510(k) Application Details - K151007

Device Classification Name	More FDA Info for this Device
510(K) Number	K151007
Device Name	21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550)
Applicant	JVC KENWOOD CORPORATION 3-12, MORIYA-CHO, KANAGAWA-KU YOKOHAMA-SHI 221-0022 JP Other 510(k) Applications for this Company
Contact	Tsukasa Tashiro 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	04/15/2015
Decision Date	05/08/2015
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