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True Definition DL

by GE Healthcare Japan Corporation

510(k) K253686

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK253686 Date23 Mar 2026ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JAK
Device class
Class II
Regulation
21 CFR Part 892.1750
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Similar devices

Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).

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