FDA 510(k) Application Details - K163429

Device Classification Name	More FDA Info for this Device
510(K) Number	K163429
Device Name	B6
Applicant	Beijing East Whale Imaging Technology Co., Ltd Unit701, Building1, Yongchang Industrial Park No.3 Yongchang North Rd., BDA Beijing 100176 CN Other 510(k) Applications for this Company
Contact	Sharon Fan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/07/2016
Decision Date	01/04/2017
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