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True Definition DL

FDA 510(k)

Class II (US FDA 510(k))

510(k) K253686

by GE Healthcare Japan Corporation

Identifiers

510(k) Number
K253686 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)

The True Definition DL is a deep-learning CT reconstruction function that enhances high-contrast spatial resolution for bone and lung imaging on compatible CT systems. It is a Class 2 Radiology device with product code JAK. The device is used for radiology applications, specifically for CT reconstruction. It is designed to improve image quality for certain types of imaging.

The True Definition DL is supplied by GE Healthcare Japan Corporation and has received FDA 510(k) clearance. It is a non-third-party device, cleared through the Traditional 510(k) pathway. The device has a specific product code, JAK, and is associated with the k number K253686. It is intended for use in radiology settings, including for bone and lung imaging on compatible CT systems.

Frequently asked questions

What is the True Definition DL device used for?

The True Definition DL is a deep-learning CT reconstruction function designed to enhance high-contrast spatial resolution specifically for bone and lung imaging on compatible CT systems. It improves image quality for these particular radiology applications.

How is the True Definition DL supplied and what is its regulatory status?

The device is supplied by GE Healthcare Japan Corporation and has received FDA 510(k) clearance through the Traditional pathway with product code JAK and k number K253686. It is a non-third-party device cleared for radiology applications.

Is the True Definition DL a single-use device or can it be reused?

The device information does not specify whether True Definition DL is single-use or reusable. As a software function for CT reconstruction, it would typically be implemented within the CT system rather than being a physical device that is disposed of after use.

What are the storage requirements for the True Definition DL?

The device data does not specify storage requirements for True Definition DL. As a software function, it would be integrated into compatible CT systems and maintained according to the system manufacturer's guidelines for software maintenance and updates.

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: True Definition DL (K253686) — FDA 510 (k) | Innolitics, True Definition DL | Ge Healthcare Japan Corporation radiology AI profile, K253686 FDA 510 (k) - True Definition DL, PDF March 23, 2026 Yonghui Han Senior Regulatory Affairs Leader 7-127 ...

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) K253686 24 fields · synced Sep 26, 2026