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 a medical device manufactured by Ge Healthcare Japan Corporation. It received FDA 510(k) clearance on 2026-03-23 under approval 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. It is manufactured by Ge Healthcare Japan Corporation. The 510(k) number is K253686.
When was True Definition DL approved by the FDA?
True Definition DL received FDA 510(k) clearance on 2026-03-23, under approval number K253686.
What company makes True Definition DL?
True Definition DL is manufactured by Ge Healthcare Japan Corporation.
What is the FDA product code for True Definition DL?
The FDA product code for True Definition DL is JAK.
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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.