Supersonic Imagine: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Supersonic Imagine” (first 2009, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 100 days. Since 2017 the median was 100 days, against 102 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 252 |
| 2013 | 2 | 68 |
| 2014 | 1 | 111 |
| 2015 | 0 | — |
| 2016 | 1 | 119 |
| 2017 | 1 | 89 |
| 2018 | 2 | 94 |
| 2019 | 1 | 192 |
| 2020 | 1 | 124 |
| 2021 | 1 | 197 |
| 2022 | 1 | 98 |
| 2023 | 0 | — |
| 2024 | 1 | 53 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Supersonic Imagine took a median 100 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | 15 | 15 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
Review panels
- Radiology (16)
Most recent Supersonic Imagine 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242223 | SuperSonic HepaVu | IYN | 2024-09-20 | 53 |
| K222191 | Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40 | IYN | 2022-10-28 | 98 |
| K203645 | Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 | IYN | 2021-06-29 | 197 |
| K202455 | Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems | IYN | 2020-12-29 | 124 |
| K191007 | Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems | IYN | 2019-10-25 | 192 |
| K180572 | AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 | IYN | 2018-05-29 | 85 |
| K173021 | Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems | IYN | 2018-01-09 | 103 |
| K171105 | AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems | IYN | 2017-07-11 | 89 |
| K161999 | Aixplorer | IYN | 2016-11-16 | 119 |
| K142100 | AIXPLORER | IYN | 2014-11-20 | 111 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Supersonic Imagine.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Supersonic Imagine is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06373796: Ultrasound Index Fat Fraction (Completed, started 2024-06-06)
- NCT03389152: SWE Liver Stiffness as a Predictor of Progression of Chronic Liver Diseases (Completed, started 2007-07-26)
Frequently asked questions
How many FDA 510(k) clearances are listed under Supersonic Imagine?
FDA lists 16 510(k) clearances under the applicant name “Supersonic Imagine” (first 2009, latest 2024), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Supersonic Imagine?
The median time from FDA receipt to decision across 510(k)s cleared under the name Supersonic Imagine is 100 days. Since 2017: 100 days, versus 102 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Supersonic Imagine?
The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 15); ITX (Transducer, Ultrasonic, Diagnostic, 1).
Next steps
- See all 16 Supersonic Imagine clearances with predicates and recalls
- Run predicate analysis for product code IYN, Supersonic Imagine's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.