The following data is part of a premarket notification filed by Dyn'r Sas with the FDA for Sdx System.
| Device ID | K121845 |
| 510k Number | K121845 |
| Device Name: | SDX SYSTEM |
| Classification | Accelerator, Linear, Medical |
| Applicant | DYN'R SAS 74 Cours Gambetta Aix En Provence, FR 13100 |
| Contact | Tim Lawton |
| Correspondent | Tim Lawton DYN'R SAS 74 Cours Gambetta Aix En Provence, FR 13100 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-25 |
| Decision Date | 2012-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760290230156 | K121845 | 000 |