Device Classification Name |
Solid State X-Ray Imager (Flat Panel/Digital Imager)
|
510(k) Number |
K133782 |
Device Name |
NOVA FA DR SYSTEM |
Applicant |
SEDECAL SA |
8870 RAVELLO CT. |
NAPLES,
FL
34114
|
|
Applicant Contact |
DANIEL KAMM, P.E. |
Correspondent |
SEDECAL SA |
8870 RAVELLO CT. |
NAPLES,
FL
34114
|
|
Correspondent Contact |
DANIEL KAMM, P.E. |
Regulation Number | 892.1680
|
Classification Product Code |
|
Date Received | 12/12/2013 |
Decision Date | 03/21/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|