FDA 510(k) Application Details - K093066

Device Classification Name	More FDA Info for this Device
510(K) Number	K093066
Device Name	I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
Applicant	INFIMED, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 US Other 510(k) Applications for this Company
Contact	JIGAR SHAH Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2009
Decision Date	03/16/2010
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