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E-Cube 15 Diagnostic Ultrasound System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K150773

by ALPINION MEDICAL SYSTEMS Co., Ltd.

Identifiers

510(k) Number
K150773 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 15 Diagnostic Ultrasound System is a portable, high-resolution ultrasound device designed for diagnostic imaging of internal body structures. It employs advanced ultrasound technology to generate real-time visualizations of organs, tissues, and blood flow, aiding in the assessment of anatomical and pathological conditions.

This system is supplied as a reusable medical device and is intended for use in clinical settings such as hospitals, diagnostic centers, and private practices. It is classified under the product code IYN and has received FDA 510(k) clearance and MDR authorization. The device is manufactured by Alpinion Medical Systems Co., Ltd., and operates within standard MRI safety guidelines for non-MRI environments.

Frequently asked questions

Is the E-CUBE 15 Diagnostic Ultrasound System designed for single-use or can it be reused in a clinical setting?

The E-CUBE 15 is explicitly supplied as a reusable medical device, intended for repeated use in clinical environments like hospitals, diagnostic centers, and private practices. Since it is not labeled as disposable, proper cleaning, disinfection, and maintenance procedures must be followed to ensure safe and effective reuse.

What types of clinical environments is the E-CUBE 15 Diagnostic Ultrasound System intended for, and how does its portability factor into its use?

The E-CUBE 15 is designed for portable diagnostic imaging in settings such as hospitals, diagnostic centers, and private practices. Its portability allows for flexibility in patient care, enabling imaging to be performed at the bedside or in areas where traditional ultrasound systems may not be as easily accessible. The system is optimized for real-time visualization of internal structures, making it suitable for a wide range of anatomical assessments.

How does the E-CUBE 15 Diagnostic Ultrasound System comply with safety standards, particularly in relation to MRI environments?

The E-CUBE 15 operates within standard MRI safety guidelines for non-MRI environments, meaning it is not intended for use inside MRI rooms or areas with strong magnetic fields. Clinicians should ensure the device is used in compliance with these guidelines to avoid interference or safety risks, particularly in mixed-use facilities where MRI and ultrasound imaging may occur.

What regulatory pathways has the E-CUBE 15 Diagnostic Ultrasound System undergone, and which advisory committee was involved in its review?

The E-CUBE 15 has received FDA 510(k) clearance and MDR authorization, indicating it has undergone regulatory review for safety and performance. The device was reviewed by the Radiology (RA) Advisory Committee under the product code IYN, with a decision of Substantially Equivalent (SESE) to a predicate device. This means the system was deemed comparable in terms of safety and effectiveness to existing ultrasound technologies.

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: É – Wikipedia

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) K150773 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 18, 2026