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
|
|
Correspondent Contact |
OMID KIA |
Regulation Number | 892.1650
|
Classification Product Code |
|
Subsequent Product Code |
|
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
|
|
|