FDA 510(k) Application Details - K052341

Device Classification Name	System, X-Ray, Mobile   More FDA Info for this Device
510(K) Number	K052341
Device Name	System, X-Ray, Mobile
Applicant	JPI AMERICA, INC. 141 CENTRAL AVE., SUITE A FARMINGDALE, NY 11735-6903 US Other 510(k) Applications for this Company
Contact	ABE ELGOHARY 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	08/26/2005
Decision Date	10/07/2005
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