Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

True Definition DL

K-Number: K253686 · 2026-03-23

ApplicantGe Healthcare Japan Corporation
Decision Date2026-03-23
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

True Definition DL is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Japan Corporation. It received FDA 510(k) clearance on 2026-03-23 under 510(k) number K253686. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the True Definition DL?

True Definition DL is a medical device that received FDA 510(k) clearance on 2026-03-23. The listed applicant is Ge Healthcare Japan Corporation. The 510(k) number is K253686.

When did True Definition DL receive FDA 510(k) clearance?

True Definition DL received FDA 510(k) clearance on 2026-03-23, under 510(k) number K253686.

Who is the listed applicant for True Definition DL?

The FDA 510(k) record lists Ge Healthcare Japan Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for True Definition DL?

The FDA product code for True Definition DL is JAK.

Other records listing Ge Healthcare Japan Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233698True Enhance DLK230807Deep Learning Image ReconstructionK220961Deep Learning Image ReconstructionK213938Revolution AscendK212067Deep Learning Image ReconstructionK203169Revolution Ascend

View all 8 devices →

Related Devices (Code: JAK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLCK253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationK253649Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑