AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach …
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180572 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 Mach Ultrasound Diagnostic Systems are portable, high-resolution ultrasound devices designed for a range of diagnostic imaging applications. These systems fall under the category of diagnostic ultrasound imaging devices, providing real-time visualization of anatomical structures through the use of ultrasound transducers. The Aixplorer Mach 30, Mach 20, and Mach 10 models are engineered to deliver enhanced imaging performance, supporting applications such as abdominal, vascular, musculoskeletal, OB-GYN, and pediatric evaluations. Their advanced imaging technology enables precise measurement and assessment of tissues and organs.
The Aixplorer Mach systems are intended for use in clinical settings, including hospitals, diagnostic centers, and private practices. These devices are supplied as reusable medical equipment, requiring proper maintenance and sterilization protocols where applicable. The systems are not classified as MRI-safe or MRI-conditional, and their use must adhere to standard ultrasound safety guidelines. Each model (Mach 30, Mach 20, Mach 10) is designed with varying specifications to accommodate different clinical workflows and imaging demands. The devices hold FDA clearance under the 510(k) pathway, with the Mach models classified under product code IYN (Diagnostic Ultrasound Systems)
Frequently asked questions
What clinical applications are the Aixplorer Mach ultrasound systems designed for?
The Aixplorer Mach systems are engineered for real-time diagnostic imaging across multiple specialties, including abdominal, vascular, musculoskeletal, obstetrics/gynecology (OB-GYN), and pediatric evaluations. Their advanced imaging technology enables precise visualization and measurement of anatomical structures, supporting comprehensive assessments in these areas.
Are the Aixplorer Mach models reusable or single-use devices?
The Aixplorer Mach systems are reusable medical devices. As such, they require adherence to proper maintenance and sterilization protocols to ensure safety and performance in clinical settings. Transducers and other consumable components may follow single-use guidelines, depending on manufacturer recommendations.
How do the Mach 30, Mach 20, and Mach 10 models differ?
The Aixplorer Mach 30, Mach 20, and Mach 10 models are differentiated by their specifications, which are tailored to accommodate varying clinical workflows and imaging demands. While exact technical distinctions (e.g., resolution, transducer options, or processing power) are not detailed here, each model is designed to optimize performance for specific diagnostic needs within the broader categories of abdominal, vascular, OB-GYN, and pediatric imaging.
What safety considerations apply to these ultrasound systems?
The Aixplorer Mach systems are not classified as MRI-safe or MRI-conditional, meaning they should not be used in MRI environments unless explicitly approved for such settings. Their use must comply with standard ultrasound safety guidelines, including proper transducer handling, patient positioning, and adherence to thermal and mechanical output limits to minimize risks.
What regulatory pathway was followed for FDA clearance of these devices?
The Aixplorer Mach ultrasound systems received FDA clearance through the 510(k) pathway, specifically under the product code IYN (Diagnostic Ultrasound Systems). The clearance was determined by the Radiology Advisory Committee (RA) and classified as substantially equivalent to a predicate device, ensuring compliance with U.S. regulatory standards for diagnostic ultrasound imaging.
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: SuperSonic™ MACH™ 30 ultrasound system | Hologic, PDF Aixplorer Mach 30 and Aixplorer Mach 20, Catalogue - Aixplorer MACH 30 PDF - Scribd, PDF AIXPLORER MACH 30 AND AIXPLORER MACH 20 - Hyppo Labor |
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180572 | Class II | Active |
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Manufacturer
- Manufacturer
- Supersonic Imagine
Sources (1)
- FDA 510(k) K180572 24 fields · synced Oct 1, 2026