FDA 510(k) Application Details - K070634

Device Classification Name	System, X-Ray, Mobile   More FDA Info for this Device
510(K) Number	K070634
Device Name	System, X-Ray, Mobile
Applicant	SOYEE PRODUCT, INC. 30 NORTHPORT RD. SOUND BEACH, NY 11789 US Other 510(k) Applications for this Company
Contact	STEPHEN T MLCOCH Other 510(k) Applications for this Contact
Regulation Number	892.1720   More FDA Info for this Regulation Number
Classification Product Code	IZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/07/2007
Decision Date	07/11/2007
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