# GenIQ

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/geniq-llz>
- Manufacturer: [GE Medical Systems, Inc.](https://devicerts.com/manufacturers/ge-medical-systems-inc) (United States)
- Device class: Class II (US FDA)
- FDA product code: LLZ

## Overview

*AI-generated summary, 2026-09-22. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

GenIQ is a medical device manufactured by GE Medical Systems, LLC. It is identified under FDA 510(k) clearance K143368.

This device is subject to FDA 510(k) premarket notification requirements. It is categorized under the radiology advisory committee and product code LLZ.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K143368 · decision 2015-07-29 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K143368 [FDA 510(k)]
- FDA product code: LLZ [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 892.2050 [FDA 510(k)]
- Advisory committee: Radiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: GenIQ, GE Medical Systems, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/geniq-llz (data as of 2026-11-14).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/geniq-llz.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/geniq-llz
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.