The following data is part of a premarket notification filed by Supersonic Imagine with the FDA for Aixplorer Mach30 / Supersonic Mach30, Aixplorer Mach20 / Supersonic , Mach20, Supersonic Mach40.
| Device ID | K222191 |
| 510k Number | K222191 |
| Device Name: | Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SuperSonic Imagine Zac De L`enfant 135 Rue Emilien Gautier Aix En Provence, FR 13290 |
| Contact | Shalyna Bansropun |
| Correspondent | Shalyna Bansropun SuperSonic Imagine Zac De L`enfant 135 Rue Emilien Gautier Aix En Provence, FR 13290 |
| 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 | 2022-07-22 |
| Decision Date | 2022-10-28 |