Identifiers
- 510(k) Number
- K223564 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 comprehensive imaging in clinical settings. These devices leverage advanced transducer technology and imaging algorithms to deliver high-resolution images, supporting accurate diagnostic evaluations across a range of applications.
The systems are intended for use in radiology environments and are supplied as reusable medical devices. Authorized under FDA 510K and MDR regulations, they are classified under product code IYN. No third-party review was required for clearance, and both models are intended for professional clinical use.
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 Medical Systems X-CUBE 50 User Manual, ALPINION, 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 | K223564 | Class II | Active |
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Manufacturer
- Manufacturer
- ALPINION MEDICAL SYSTEMS Co., Ltd.
Sources (2)
- FDA 510(k) K223564 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026