The following data is part of a premarket notification filed by Stephanix Radiological Systems with the FDA for D2rf Digital Dynamic Remote System.
| Device ID | K102529 |
| 510k Number | K102529 |
| Device Name: | D2RF DIGITAL DYNAMIC REMOTE SYSTEM |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | STEPHANIX RADIOLOGICAL SYSTEMS 8870 RAVELLO COURT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm STEPHANIX RADIOLOGICAL SYSTEMS 8870 RAVELLO COURT Naples, FL 34114 |
| Product Code | OWB |
| Subsequent Product Code | IZI |
| Subsequent Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-02 |
| Decision Date | 2010-10-07 |
| Summary: | summary |