Identifiers
- 510(k) Number
- K213523 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 i8 and X-CUBE i9 are portable ultrasound systems designed for high-resolution imaging. These devices provide real-time diagnostic imaging, enabling clinicians to visualize internal body structures such as organs, tissues, and blood flow for diagnostic and monitoring purposes.
The X-CUBE i8 and X-CUBE i9 are supplied as reusable medical devices and are intended for use in clinical settings. They are authorized under FDA 510K clearance (K213523) and comply with the Medical Device Regulation (MDR). The systems are classified under product code IYN and reviewed by the Radiology Advisory Committee (RA) for substantial equivalence.
Frequently asked questions
Are the X-CUBE i8 and X-CUBE i9 systems portable and designed for clinical use in hospitals or outpatient settings?
Yes, the X-CUBE i8 and X-CUBE i9 are explicitly designed as portable ultrasound systems for clinical settings. Their portability allows for flexible use in hospitals, outpatient clinics, or other healthcare environments where real-time diagnostic imaging is required. The devices are intended to visualize internal structures like organs, tissues, and blood flow, making them suitable for a variety of diagnostic and monitoring applications.
How are the X-CUBE i8 and X-CUBE i9 systems classified under regulatory frameworks, and which advisory committee reviewed their substantial equivalence?
The X-CUBE i8 and X-CUBE i9 are classified under FDA product code IYN and were reviewed by the Radiology Advisory Committee (RA) for substantial equivalence. Their regulatory route involved a Traditional 510(k) clearance process, with the decision confirming they are substantially equivalent to a legally marketed predicate device. Additionally, they comply with the Medical Device Regulation (MDR) outside the U.S.
Are the X-CUBE i8 and X-CUBE i9 systems single-use or reusable, and what does this mean for maintenance and cleaning?
The X-CUBE i8 and X-CUBE i9 are reusable medical devices, meaning they are designed for repeated use in clinical settings after proper cleaning, disinfection, and maintenance. This allows healthcare facilities to maintain a single system while ensuring hygiene standards are met through established reprocessing protocols. Reusability also supports cost efficiency and reduces waste compared to single-use alternatives.
What does the FDA clearance number (K213523) indicate about the X-CUBE i8 and X-CUBE i9 systems, and when was this decision made?
The FDA clearance number K213523 confirms that the X-CUBE i8 and X-CUBE i9 systems received 510(k) clearance under the Traditional review pathway, demonstrating they are substantially equivalent to a previously approved device. This decision was made on January 28, 2022, following a review process that began on November 3, 2021, ensuring compliance with U.S. regulatory requirements for diagnostic ultrasound systems.
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.
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 | K213523 | Class II | Active |
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Manufacturer
- Manufacturer
- ALPINION MEDICAL SYSTEMS Co., Ltd.
Sources (2)
- FDA 510(k) K213523 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026