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True Enhance DL

FDA 510(k)

Class II (US FDA 510(k))

510(k) K233698

by GE Healthcare Japan Corporation

Identifiers

510(k) Number
K233698 FDA 510(k)
FDA Product Code
JAK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1750 FDA 510(k)
Regulation Number
892.1750 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

True Enhance DL is an AI-enabled deep learning image reconstruction device designed for computed tomography (CT) imaging. It enhances image quality by processing complex models and parameters to improve diagnostic accuracy and reduce noise in CT scans, aligning with the principles of advanced radiologic reconstruction technology.

The device is supplied as a software solution integrated into GE Healthcare’s CT systems and is intended for single-use applications within clinical radiology settings. It is not sterile and requires no special storage conditions beyond standard IT infrastructure. Authorized for use in the United States under FDA 510(k) clearance (K233698), True Enhance DL is classified under the Radiology Advisory Committee and is substantively equivalent to existing predicate devices.

Frequently asked questions

What clinical setting is True Enhance DL intended for, and how does it integrate with existing systems?

True Enhance DL is designed specifically for clinical radiology settings where computed tomography (CT) imaging is performed. As a software solution, it is integrated into GE Healthcare’s CT systems, meaning it does not require additional hardware but relies on the existing IT infrastructure of the CT scanner. This makes it a seamless upgrade for facilities already using GE Healthcare’s CT technology, enhancing image quality without disrupting workflows.

Is True Enhance DL reusable, or is it meant for single-use applications, and what does that mean for maintenance?

True Enhance DL is explicitly intended for single-use applications within clinical radiology. This means each scan processed through the device is treated as a distinct session, and the software does not require reprocessing or cleaning between uses. Since it is a software solution, maintenance primarily involves ensuring the underlying CT system’s IT infrastructure remains updated and functional, rather than physical device upkeep.

Does True Enhance DL require any special storage conditions, and what are the implications for its deployment?

True Enhance DL does not require any special storage conditions beyond standard IT infrastructure. Since it is a software-based solution integrated into GE Healthcare’s CT systems, deployment only necessitates compatibility with the existing hardware and network setup. This simplifies logistics, as no additional environmental controls (like temperature or humidity) are needed, and it can be deployed wherever the CT system is already operational.

How does True Enhance DL improve diagnostic accuracy, and what type of CT scans is it compatible with?

True Enhance DL improves diagnostic accuracy by leveraging AI-enabled deep learning to reduce noise and enhance image quality in CT scans. While the exact types of scans it is compatible with are not detailed in the data, its design aligns with advanced radiologic reconstruction technology, suggesting it can be applied broadly to CT imaging—including but not limited to abdominal, thoracic, or vascular scans—where clearer images are critical for accurate diagnosis. The enhancement is achieved through processing complex models and parameters tailored to the CT system’s output.

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 Healthcare Japan Corporation: True Enhance DL (FDA-cleared AI ..., True Enhance DL, PDF April 11, 2024 Laura Turner Regulatory Affairs Manager, Premium CT JAPAN

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
GE Healthcare Japan Corporation

Sources (1)

  • FDA 510(k) K233698 24 fields · synced Sep 19, 2026