FDA 510(k) Application Details - K203733

Device Classification Name	More FDA Info for this Device
510(K) Number	K203733
Device Name	12MP Color Digital Mammography LCD Monitor CL-S1200
Applicant	JVCKENWOOD Corporation 3-12, Moriya-cho, Kanagawa-ku Yokohama 221-0022 JP Other 510(k) Applications for this Company
Contact	Hideki Tengeiji 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	12/21/2020
Decision Date	06/29/2021
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