AIXPLORER® & AIXPLORER® Ultimate Ultrasound Systems
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171105 FDA 510(k)
- FDA Product Code
- IYN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1550 FDA 510(k)
- Regulation Number
- 892.1550 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Aixplorer and Aixplorer Ultimate Ultrasound Systems are diagnostic ultrasound devices designed for high-speed imaging of anatomical structures. These systems utilize advanced imaging technology to capture detailed images of abdominal organs, small organs, musculoskeletal tissues, vascular structures, and other regions, including intraoperative, OB-GYN, pelvic, pediatric, urology, and trans-rectal applications. Their primary function is to provide real-time visualization and measurement capabilities for clinical assessment and diagnostic purposes.
These systems are supplied by SuperSonic Imagine and are intended for use in clinical settings. The Aixplorer and Aixplorer Ultimate are classified under product code IYN and have received FDA 510(k) clearance through a Traditional review pathway, with a decision date of July 11, 2017. They are not specified as single-use or reusable, nor are there details on sterility or MRI safety in the provided data. The systems are manufactured in Aix-en-Provence, France.
Frequently asked questions
What clinical applications does the Aixplorer® Ultimate support?
The Aixplorer® Ultimate is designed for high-speed imaging of anatomical structures across multiple specialties, including abdominal organs, musculoskeletal tissues, vascular structures, OB-GYN, pelvic, pediatric, urology, and trans-rectal applications. Its advanced technology enables real-time visualization and precise measurements, making it suitable for intraoperative assessments and diagnostic evaluations in these areas.
How is the Aixplorer® system supplied and where is it manufactured?
The Aixplorer® and Aixplorer® Ultimate systems are supplied by SuperSonic Imagine and are intended for use in clinical settings. They are manufactured in Aix-en-Provence, France, at the facility located at Les Jardins De La Duranne.
Is the Aixplorer® Ultimate system single-use or reusable?
The provided data does not specify whether the Aixplorer® Ultimate system is single-use or reusable. Typically, ultrasound systems like this are designed for reusable components, but the transducers or probes may be single-use or reusable depending on the model and clinical protocol. Always refer to the manufacturer’s instructions for proper use and reprocessing guidelines.
What regulatory pathway was followed for FDA clearance?
The Aixplorer® and Aixplorer® Ultimate Ultrasound Systems received FDA 510(k) clearance through a Traditional review pathway. The decision was made by the Radiology (RA) Advisory Committee on July 11, 2017, with the device classified under product code IYN and determined to be substantially equivalent to a predicate device.
Are there any details on sterility or MRI safety for the Aixplorer® systems?
The provided data does not include specific information regarding sterility or MRI safety for the Aixplorer® or Aixplorer® Ultimate systems. For MRI compatibility, it is essential to consult the manufacturer’s documentation or contact SuperSonic Imagine directly, as this can vary based on individual components and configurations.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: About Us - supersonicimagine.com, Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems, Aixplorer® and Aixplorer® Ultimate Ultrasound Diagnostic Systems ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171105 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Supersonic Imagine
Sources (1)
- FDA 510(k) K171105 24 fields · synced Oct 1, 2026