The following data is part of a premarket notification filed by Supersonic Imagine with the FDA for Aixplorer Mach 30, Aixplorer Mach 20 Ultrasound Diagnostic Systems.
| Device ID | K191007 |
| 510k Number | K191007 |
| Device Name: | Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Supersonic Imagine Les Jardins De La Duranne - Bat E&F - 510 Rue Rene Descartes Aix-en-provence, FR 13857 |
| Contact | Jacques Souquet |
| Correspondent | Jacques Souquet Supersonic Imagine Les Jardins De La Duranne - Bat E&F - 510 Rue Rene Descartes Aix-en-provence, FR 13857 |
| 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 | 2019-04-16 |
| Decision Date | 2019-10-25 |
| Summary: | summary |