# Supersonic Imagine

- Location (FDA's records): Aix-En-Provence  Cedex, FR
- FDA decisions: 16 (2009–2024): 16 510(k) clearances
- Product codes: IYN (15), ITX (1)
- 510(k) review time since 2016: median 103 days, against 85 for FDA's reviews in the same codes and years (2 of 9 faster)
- Predicates its devices cite: 39 (20 its own); citations of its devices by later devices: 38 (20 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Philips Ultrasound, Inc.: 6 (https://510kreport.com/company/philips-ultrasound)
- Siemens Medical Solutions USA, Inc.: 5 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Toshibamedical Systems Corporation: 3 (https://510kreport.com/company/toshibamedical-systems)
- Echosens: 2 (https://510kreport.com/company/echosens)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)
- Esaote, S.p.A.: 1 (https://510kreport.com/company/esaote)
- Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-mindray-bio-meidcal-electronics)

## Firms that cite its devices most
- Siemens Medical Solutions USA, Inc.: 6 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Philips Ultrasound, Inc.: 3 (https://510kreport.com/company/philips-ultrasound)
- Echosens: 3 (https://510kreport.com/company/echosens)
- Samsung Medison Co., Ltd.: 2 (https://510kreport.com/company/samsung-medison)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)
- Toshibamedical Systems Corporation: 1 (https://510kreport.com/company/toshibamedical-systems)
- Canon Medical Systems Corporation: 1 (https://510kreport.com/company/canon-medical-systems)
- Esonic Technology (Wuhan) Co., Ltd.: 1 (https://510kreport.com/company/esonic-technology-wuhan)

## Its most-cited devices
- K112255: Aixplorer (2012), cited by 9
- K132274: Aixplorer (2013), cited by 6
- K121329: Aixplorer (2012), cited by 5
- K191007: Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems (2019), cited by 3
- K173021: Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems (2018), cited by 2
- K091970: Aixplorer Ultrasound System (2009), cited by 2

## Recent decisions
- 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 Ultrasonic Diagnostic Systems (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)

Source page: https://510kreport.com/company/supersonic-imagine