The following data is part of a premarket notification filed by Koelis with the FDA for Trinity/3d Prostate Suite.
| Device ID | K170521 |
| 510k Number | K170521 |
| Device Name: | TRINITY/3D PROSTATE SUITE |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | KOELIS 16, Chemin Du Vieux Chene Meylan, FR 38240 |
| Contact | Laetitia Gervais |
| Correspondent | Laetitia Gervais KOELIS 16, Chemin Du Vieux Chene Meylan, FR 38240 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-22 |
| Decision Date | 2017-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03665134000691 | K170521 | 000 |
| 03665134000714 | K170521 | 000 |
| 03665134000530 | K170521 | 000 |
| 03665134000523 | K170521 | 000 |
| 03665134000516 | K170521 | 000 |
| 03665134000509 | K170521 | 000 |
| 03665134000929 | K170521 | 000 |