Logiq E10
by GE Medical Systems Ultrasound and Primary Care Diagnostics United States EUDAMED510(k)
510(k) K231966
Product code IYN
Overview
The Logiq E10 is a portable ultrasound system, classified as a diagnostic imaging device under the Radiology advisory committee category. It provides real-time imaging for visualizing internal body structures using high-frequency sound waves, enabling diagnostic evaluation of organs, tissues, and blood flow.
This device is supplied as a reusable system, intended for use in clinical settings such as hospitals, outpatient clinics, and emergency departments. It is not sterile and requires proper cleaning and maintenance per manufacturer guidelines. The Logiq E10 holds FDA 510(k) clearance under the Traditional pathway and is also authorized under the EU Medical Device Regulation (MDR), with a product code of IYN.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK231966 | Date7 Nov 2023 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- IYN
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
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Questions
What clinical settings is the Logiq E10 designed for, and how is it typically used there?
The Logiq E10 is a portable ultrasound system intended for use in clinical environments like hospitals, outpatient clinics, and emergency departments. It provides real-time imaging to help clinicians visualize internal structures, organs, tissues, and blood flow, aiding in diagnostic evaluations. Its portability makes it suitable for bedside assessments, point-of-care diagnostics, and situations where mobility is essential.
Is the Logiq E10 meant for single-use or reusable applications, and what maintenance does it require?
The Logiq E10 is a reusable system, not intended for single-use. Since it is not sterile, it requires thorough cleaning and maintenance following the manufacturer’s guidelines to ensure proper functionality and infection control in clinical settings.
How is the regulatory approval process for the Logiq E10 structured, and what does its classification mean?
The Logiq E10 holds FDA clearance through the 510(k) Traditional pathway, classified under the Radiology advisory committee (RA) with a product code of IYN. This means it was determined to be substantially equivalent to a legally marketed device already on the market, fulfilling regulatory requirements for diagnostic imaging devices. It is also authorized under the EU Medical Device Regulation (MDR).
What types of diagnostic evaluations can the Logiq E10 support, and why is real-time imaging important?
The Logiq E10 supports diagnostic evaluations of organs, tissues, and blood flow through high-frequency sound waves, enabling real-time imaging. This capability is critical for immediate assessments in dynamic clinical scenarios, such as emergency care, obstetrics, or cardiology, where timely visualization of internal structures can directly influence patient management decisions.
Properties & raw data
Show properties, registry sources and raw records
Sources (2)
- FDA 510(k) K231966
- EUDAMED