The following data is part of a premarket notification filed by Koelis with the FDA for 3d Prostate Suite 3dtrus Prostate Mapping, Mri/3dtrus Fusion Option, Second Look 3dtrus Fusion Option.
| Device ID | K131448 |
| 510k Number | K131448 |
| Device Name: | 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION |
| Classification | System, Image Processing, Radiological |
| Applicant | KOELIS 5 Avenue Du Grand Sablon La Tronche, FR 38700 |
| Contact | Laetitia Gervais |
| Correspondent | Laetitia Gervais 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 | 2013-05-20 |
| Decision Date | 2013-07-26 |
| Summary: | summary |