Identifiers
- 510(k) Number
- K221093 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 X-Cube 70 and X-Cube 90 are portable ultrasound systems designed for diagnostic imaging. They incorporate high-resolution, high-sensitivity transducers and advanced imaging software to support a range of clinical applications, including radiology procedures.
These devices are supplied as reusable medical equipment, intended for use in clinical settings such as hospitals and diagnostic centers. Authorized under FDA 510K clearance and MDR compliance, they are regulated as substantially equivalent to predicate devices in radiology imaging. No third-party review was involved in their authorization.
Frequently asked questions
Are the X-CUBE 70 and X-CUBE 90 systems designed for single-use or reusable in clinical settings, and how does this impact their maintenance requirements?
The X-CUBE 70 and X-CUBE 90 are explicitly supplied as reusable medical equipment, meaning they are built for repeated use in clinical environments like hospitals and diagnostic centers. Since they are reusable, proper cleaning, disinfection, and maintenance protocols must be followed to ensure sterility and functionality between uses. The manufacturer’s instructions should outline these procedures to comply with regulatory standards and prevent cross-contamination.
What types of clinical applications are these ultrasound systems intended to support, and how does their design accommodate those needs?
The X-CUBE 70 and X-CUBE 90 are designed for diagnostic imaging across a broad range of radiology procedures, leveraging high-resolution and high-sensitivity transducers paired with advanced imaging software. Their portability and adaptability make them suitable for general radiology, abdominal, vascular, musculoskeletal, and other ultrasound-guided assessments. The systems prioritize versatility to meet diverse clinical workflows without requiring specialized configurations.
How are the X-CUBE 70 and X-CUBE 90 regulated, and what does their authorization status imply about their compliance with safety and performance standards?
Both models are authorized under FDA 510K clearance and MDR compliance, with a decision classification of *Substantially Equivalent* to predicate devices in the Radiology category. This means the FDA determined they meet the same performance and safety requirements as existing, legally marketed ultrasound systems. Their regulatory route confirms adherence to stringent quality, safety, and effectiveness standards for diagnostic imaging equipment, though compliance remains the responsibility of the facility using them.
What distinguishes the X-CUBE 70 from the X-CUBE 90 in terms of specifications or intended use, and how might clinicians choose between them?
While the provided data does not specify exact technical differences (e.g., resolution, transducer types, or processing power), the X-CUBE 70 and X-CUBE 90 are differentiated by their model numbers, which typically correlate to variations in performance or feature sets. Clinicians might select the 70 for standard diagnostic needs or resource-constrained settings, while the 90 could offer enhanced capabilities (e.g., higher frame rates or expanded imaging modes) for complex cases. The choice depends on workflow demands, budget, and the specific imaging challenges faced in their practice.
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: ALPINION, ALPINION, Alpinion X-CUBE 70 with Elite - USC Imaging, PDF October 14, 2022 Alpinion Medical Systems Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K221093 | Class II | Active |
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Manufacturer
- Manufacturer
- ALPINION MEDICAL SYSTEMS Co., Ltd.
Sources (2)
- FDA 510(k) K221093 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026