The following data is part of a premarket notification filed by Koelis with the FDA for Urostation 3d Prostate Suite.
| Device ID | K100793 |
| 510k Number | K100793 |
| Device Name: | UROSTATION 3D PROSTATE SUITE |
| Classification | System, Image Processing, Radiological |
| Applicant | KOELIS 5 Avenue Du Grand Sablon La Tronche, FR 38700 |
| Contact | Cecile Desmulie |
| Correspondent | Cecile Desmulie KOELIS 5 Avenue Du Grand Sablon La Tronche, FR 38700 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-22 |
| Decision Date | 2010-09-22 |
| Summary: | summary |