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LOGIQ S8

FDA 510(k)

Class II (US FDA 510(k))

510(k) K152195

by GE Healthcare

Identifiers

510(k) Number
K152195 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 LOGIQ S8 is a general ultrasound system designed for diagnostic imaging and blood flow visualization. It features advanced signal processing and Doppler capabilities, including B-Flow imaging, elastography, and multi-modality query retrieve functions.

The device is supplied as a reusable system and is not single-use. It is intended for use in clinical settings and is subject to FDA 510(k) authorization. Proper storage and handling are required to maintain its performance.

Frequently asked questions

What is the LOGIQ S8 used for?

The LOGIQ S8 is a general ultrasound system designed for diagnostic imaging and blood flow visualization. It includes advanced signal processing and Doppler capabilities, such as B-Flow imaging, elastography, and multi-modality query retrieve functions.

Is the LOGIQ S8 a single-use device?

No, the LOGIQ S8 is a reusable system intended for use in clinical settings. Proper storage and handling are required to maintain its performance.

What regulatory authorization does the LOGIQ S8 have?

The LOGIQ S8 is subject to FDA 510(k) authorization, which is a traditional clearance type. The device was reviewed by the Radiology (RA) advisory committee.

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: LOGIQ S8 | GE HealthCare (United States), PDF GE Healthcare LOGIQ S8 - ultrasoundportables.com, PDF logiq S8 brochure

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
GE Healthcare

Sources (1)

  • FDA 510(k) K152195 24 fields · synced Oct 6, 2026