The following data is part of a premarket notification filed by Pixee Medical with the FDA for Fx Sps.
| Device ID | K213922 |
| 510k Number | K213922 |
| Device Name: | FX SPS |
| Classification | System, Image Processing, Radiological |
| Applicant | Pixee Medical 18 Rue Alain Savary Besancon, FR 25000 |
| Contact | Agathe Joet |
| Correspondent | Agathe Joet Pixee Medical 18 Rue Alain Savary Besancon, FR 25000 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-15 |
| Decision Date | 2022-07-22 |