FDA 510(k) Application Details - K140399

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K140399
Device Name	System, Image Processing, Radiological
Applicant	EBM TECHNOLOGIES USA, LLC 641 Keeaumoku St Ste 5 Honolulu, HI 96814 US Other 510(k) Applications for this Company
Contact	JOHN SU 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	02/18/2014
Decision Date	09/18/2014
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