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E-Cube 8

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K181617

by ALPINION MEDICAL SYSTEMS Co., Ltd.

Identifiers

510(k) Number
K181617 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 E-Cube 8 is a portable ultrasound imaging system designed for diagnostic radiology applications. It integrates advanced imaging technology to provide high-resolution, real-time visualisation of internal body structures, supporting clinical assessments in various specialties such as obstetrics, cardiology, and general diagnostics.

This device is supplied as a reusable system, intended for use in clinical settings such as hospitals, diagnostic centres, and mobile imaging units. It is authorised under FDA 510K clearance and MDR compliance, with a traditional review process through the Radiology Advisory Committee. The system requires proper maintenance and storage as per manufacturer guidelines to ensure optimal performance and safety.

Frequently asked questions

What clinical specialties can the E-Cube 8 ultrasound system support for diagnostic imaging?

The E-Cube 8 is designed to support diagnostic radiology across multiple specialties, including obstetrics for fetal imaging, cardiology for heart assessments, and general diagnostics for evaluating internal body structures in real time. Its advanced imaging technology ensures high-resolution visualization to aid clinical decision-making in these areas.

Is the E-Cube 8 portable, and where would it be suitable for use?

Yes, the E-Cube 8 is explicitly described as a portable ultrasound imaging system, making it ideal for clinical settings like hospitals, diagnostic centers, and mobile imaging units. Its portability allows flexibility for imaging in various environments without compromising diagnostic capabilities.

How is the E-Cube 8 maintained, and what storage requirements does it have?

The E-Cube 8 is a reusable system, so it requires regular maintenance as outlined by the manufacturer to ensure optimal performance and safety. Proper storage conditions must also be followed to preserve functionality, though specific details like temperature or environmental controls are not provided in the data.

What regulatory pathways does the E-Cube 8 follow, and how was its approval process structured?

The E-Cube 8 is authorized under both FDA 510K clearance and MDR compliance. In the U.S., it underwent a traditional review process through the Radiology Advisory Committee (RA), where it was deemed substantially equivalent to a predicate device, as indicated by the decision code SESE and the product code IYN.

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

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
ALPINION MEDICAL SYSTEMS Co., Ltd.

Sources (2)

  • FDA 510(k) K181617 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026