Supersonic Imagine
Supersonic Imagine appears in FDA public data with 0 recalls, 16 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Sep 20, 2024.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 16
- Inspections
- 3
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K242223 | SuperSonic HepaVu | Sep 20, 2024 |
| K222191 | Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40 | Oct 28, 2022 |
| K203645 | Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 | Jun 29, 2021 |
| K202455 | Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultraso | Dec 29, 2020 |
| K191007 | Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems | Oct 25, 2019 |
| K180572 | AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 | May 29, 2018 |
| K173021 | Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems | Jan 9, 2018 |
| K171105 | AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems | Jul 11, 2017 |
| K161999 | Aixplorer | Nov 16, 2016 |
| K142100 | AIXPLORER | Nov 20, 2014 |
| K132171 | AIXPLORER | Sep 24, 2013 |
| K132274 | AIXPLORER | Sep 24, 2013 |
| K112255 | AIXPLORER | Aug 28, 2012 |
| K121329 | AIXPLORER | Aug 24, 2012 |
| K102041 | AIXPLORER | Oct 13, 2010 |
| K091970 | AIXPLORER ULTRASOUND SYSTEM | Aug 12, 2009 |