Identifiers
- 510(k) Number
- K220857 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 50 and X-CUBE 60 are diagnostic ultrasound systems designed for high-resolution imaging. These devices leverage advanced transducer technology and automated workflow tools to enhance diagnostic accuracy and operational efficiency in clinical settings.
The X-CUBE 50 and X-CUBE 60 are supplied as reusable medical devices, intended for use in radiology departments. Both models are authorized under FDA 510K clearance (K220857) and comply with MDR regulations. They are not classified as MRI-safe or MRI-conditional, and no specific sterility or single-use requirements are stated in the specifications.
Frequently asked questions
Are the X-CUBE 50 and X-CUBE 60 ultrasound systems designed for single-use or can they be reused in a clinical setting?
The X-CUBE 50 and X-CUBE 60 are explicitly described as reusable medical devices in the provided data. Since they are not classified as single-use and are intended for use in radiology departments, they must be properly cleaned, disinfected, and maintained between patient encounters to ensure safety and functionality.
What types of clinical workflows or specialties would benefit most from the automated workflow tools included in these ultrasound systems?
The X-CUBE 50 and X-CUBE 60 are designed with advanced transducer technology and automated workflow tools to improve diagnostic accuracy and efficiency. These features are particularly useful in radiology departments, where high-resolution imaging and streamlined processes are critical for musculoskeletal, abdominal, or vascular assessments. Clinicians may appreciate reduced setup time and enhanced image quality for routine or complex evaluations.
How do I determine which model, X-CUBE 50 or X-CUBE 60, is best suited for my facility’s needs?
The data does not specify technical differences between the X-CUBE 50 and X-CUBE 60 beyond their shared high-resolution imaging capabilities and automated workflow tools. To decide, consider factors like your facility’s workflow demands, transducer compatibility, and space requirements. Consulting with Alpinion Medical Systems or reviewing their technical specifications would provide clarity on performance distinctions, as the provided data does not detail model-specific features.
Are these ultrasound systems compatible with MRI environments, or should they be used in non-MRI settings?
The X-CUBE 50 and X-CUBE 60 are not classified as MRI-safe or MRI-conditional according to the provided data. This means they should not be used in MRI environments, as their materials or components may pose risks (e.g., interference, heating, or projectiles) when exposed to MRI magnetic fields. They are intended for standard radiology departments without MRI integration.
What regulatory pathways have these devices undergone, and how does that affect their adoption in different markets?
The X-CUBE 50 and X-CUBE 60 have undergone FDA 510(k) clearance (K220857) and comply with MDR (Medical Device Regulation) requirements. The FDA clearance indicates they are deemed substantially equivalent to a predicate device under the Radiology product code (IYN), while MDR compliance ensures they meet EU market standards. This dual authorization facilitates adoption in both U.S. and EU markets, though local regulatory requirements (e.g., additional country-specific certifications) may still apply.
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 Medical Systems X-CUBE 50 User Manual, Alpinion medical systems X-CUBE 50 Manuals | ManualsLib, PDF X-CUBE 50 - medicalscan.es
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 | K220857 | Class II | Active |
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Manufacturer
- Manufacturer
- ALPINION MEDICAL SYSTEMS Co., Ltd.
Sources (2)
- FDA 510(k) K220857 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced Jun 3, 2026