FDA 510(k) Application Details - K041213

Device Classification Name	More FDA Info for this Device
510(K) Number	K041213
Device Name	3DSCOPE
Applicant	DIREX SYSTEMS CORP. 11 MERCER RD. NATICK, MA 01760 US Other 510(k) Applications for this Company
Contact	LARISA GERSHTEIN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/10/2004
Decision Date	07/22/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review