Supersonic Imagine · Class II · Cleared Dec 29, 2020
| K-number | K202455 |
| Device name | Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems |
| Applicant | Supersonic Imagine |
| Product code | IYN |
| Device class | Class II |
| Decision date | Dec 29, 2020 |
| Decision | Substantially Equivalent |
| Regulation | 892.1550 |
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