The following data is part of a premarket notification filed by Sonoscanner with the FDA for U-lite Exp.
| Device ID | K171164 |
| 510k Number | K171164 |
| Device Name: | U-Lite EXP |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Sonoscanner 6 Rue Andre Voguet Ivry Sur Seine, FR 94200 |
| Contact | Bruno Richard |
| Correspondent | E. J. Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-20 |
| Decision Date | 2017-08-03 |
| Summary: | summary |