The following data is part of a premarket notification filed by Sedecal Sa with the FDA for Nova Fa Dr System.
| Device ID | K133782 |
| 510k Number | K133782 |
| Device Name: | NOVA FA DR SYSTEM |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | SEDECAL SA 8870 RAVELLO CT. Naples, FL 34114 |
| Contact | Daniel Kamm, P.e. |
| Correspondent | Daniel Kamm, P.e. SEDECAL SA 8870 RAVELLO CT. Naples, FL 34114 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-12 |
| Decision Date | 2014-03-21 |
| Summary: | summary |