RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM


Device Classification Name

interventional fluoroscopic x-ray system

510(k) Number K030544
Device Name RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM
Applicant
SIGMA VISION, INC.
6001 montrose rd. ste. 606
rockville, 
MD 
20852

Applicant Contact omid kia
Correspondent
SIGMA VISION, INC.
6001 montrose rd. ste. 606
rockville, 
MD 
20852

Correspodent Contact omid kia
Regulation Number 892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received 02/20/2003
Decision Date 05/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No