FDA 510(k) Application Details - K093640

Device Classification Name	System, Imaging, X-Ray, Electrostatic   More FDA Info for this Device
510(K) Number	K093640
Device Name	System, Imaging, X-Ray, Electrostatic
Applicant	ELECTRON JSCO. 55 NORTHERN BLV SUITE 200 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	TANMAY SHUKLA Other 510(k) Applications for this Contact
Regulation Number	892.1630   More FDA Info for this Regulation Number
Classification Product Code	IXK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/24/2009
Decision Date	04/29/2011
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