FDA 510(k) Application Details - K030544

Device Classification Name	More FDA Info for this Device
510(K) Number	K030544
Device Name	RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM
Applicant	SIGMA VISION, INC. 6001 MONTROSE RD. STE. 606 ROCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	OMID KIA 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	02/20/2003
Decision Date	05/21/2003
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