FDA 510(k) Application Details - K981466

Device Classification Name	System, X-Ray, Mobile   More FDA Info for this Device
510(K) Number	K981466
Device Name	System, X-Ray, Mobile
Applicant	IMAGING SCIENCES INTL., INC. 941 HAMILTON AVE. ROEBLING, NJ 08554 US Other 510(k) Applications for this Company
Contact	ROBERT E HAY 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	04/23/1998
Decision Date	07/14/1998
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