The following data is part of a premarket notification filed by Stephanix Radiological Solutions with the FDA for D2rs_at Digital Dynamic Remote System.
| Device ID | K150306 |
| 510k Number | K150306 |
| Device Name: | D2RS_AT Digital Dynamic Remote System |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | STEPHANIX RADIOLOGICAL SOLUTIONS RUE JEAN MOULIN ZI DU BAYOU La Ricamarie, FR 42150 |
| Contact | Sandie Perret |
| Correspondent | Daniel Kamm Kamm & Associates 8870 RAVELLO CT. Naples, FL 34114 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-09 |
| Decision Date | 2015-10-10 |
| Summary: | summary |