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Logiq 700 With Coded Excitation Modification

FDA 510(k)

Class II (US FDA 510(k))

510(k) K993364

by Ge Medical Systems, Inc.

Identifiers

510(k) Number
K993364 FDA 510(k)
FDA Product Code
IYO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1560 FDA 510(k)
Regulation Number
892.1560 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Logiq 700 With Coded Excitation Modification is a mobile diagnostic ultrasound console (128-channel) classified as a system, imaging, pulsed echo, ultrasonic device. It processes ultrasonic pulsed echo signals from various probes using Coded Excitation (CE) technology to enhance B or M mode performance, improving high-frequency depth penetration while maintaining spatial resolution.

This device is intended for use in radiology settings and has received FDA 510(k) clearance under Special review (K993364). It is supplied as a reusable medical imaging system, with no explicit mention of sterility or MRI safety in the provided data. The console operates as part of a diagnostic imaging workflow, requiring appropriate training and maintenance in accordance with regulatory standards.

Frequently asked questions

What is the primary purpose of the GE Logiq 700 with Coded Excitation Modification in clinical settings?

The GE Logiq 700 with Coded Excitation Modification is designed to enhance diagnostic ultrasound imaging by improving high-frequency depth penetration while preserving spatial resolution. It uses Coded Excitation (CE) technology to process ultrasonic signals from probes, making it particularly useful for radiology applications where clearer, deeper imaging is required in B or M mode.

Is the GE Logiq 700 with Coded Excitation Modification intended for single-use or reusable in clinical environments?

The device is explicitly described as a reusable medical imaging system. Since it is a console-based ultrasound machine, it is not intended for single-use and requires proper maintenance and cleaning protocols to ensure reliable performance and infection control.

How is the regulatory status of this device determined, and what does that mean for potential buyers?

The GE Logiq 700 with Coded Excitation Modification received FDA 510(k) clearance under Special Review (K993364) and was classified as substantially equivalent to a predicate device. This means it has undergone regulatory evaluation to confirm its safety and effectiveness for its intended use in radiology settings, but buyers should verify compliance with current FDA and institutional requirements before procurement.

What type of training or expertise is required to operate this ultrasound system effectively?

Since this is a mobile diagnostic ultrasound console, it is designed for use by trained radiologists, sonographers, or other qualified healthcare professionals familiar with ultrasound imaging workflows. Proper training in system operation, probe selection, and image interpretation is essential, as outlined in the manufacturer’s instructions and regulatory standards.

Does the device include any specific storage or handling requirements beyond standard medical equipment protocols?

The provided data does not specify unique storage conditions beyond general medical equipment guidelines. However, as a reusable imaging system, it should be stored in a clean, dry environment away from extreme temperatures or direct sunlight to prevent damage. Maintenance and calibration should follow the manufacturer’s recommendations to ensure optimal performance.

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: Ge Logiq 700 With Coded Excitation Modification, GE LOGIQ 700 WITH CODED EXCITATION MODIFICATION 510 (k) K993364 - FDA ..., www.accessdata.fda.gov

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ge Medical Systems, Inc.

Sources (1)

  • FDA 510(k) K993364 24 fields · synced Oct 6, 2026