AIXPLORER— 510(k) K102041
Substantially EquivalentSupersonic Imagine
FDA 510(k) clearance K102041 for AIXPLORER, Substantially Equivalent on 2010-10-13. Applicant: Supersonic Imagine. Device class: 2.
Clearance details
- Applicant
- Supersonic Imagine
- Product code
- Code ITX
- Device class
- Class 2
- Regulation
- 21 CFR 892.1570
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Aix-En-Provence Cedex, FR
Recent devices under product code ITX
view allMore clearances from Supersonic Imagine
view all- K242223 — SuperSonic HepaVu
- K222191 — Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40
- K203645 — Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40
- K202455 — Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems
- K191007 — Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems
Adverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.