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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / March 2026 / K253686

510(k) cleared

True Definition DL

Ge Healthcare Japan Corporation · Mar 23, 2026 · K253686

FDA cleared the True Definition DL from Ge Healthcare Japan Corporation on Mar 23, 2026 under K253686, a traditional 510(k). The device falls under product code JAK, System, X-Ray, Tomography, Computed, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 21, 2025. The decision came 122 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Ge Healthcare Japan Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253686?

K253686 is the FDA 510(k) for True Definition DL, submitted by Ge Healthcare Japan Corporation. FDA's decision date was Mar 23, 2026, under product code JAK (System, X-Ray, Tomography, Computed).

Who makes the True Definition DL?

Ge Healthcare Japan Corporation, based in Hino-Shi, Tokyo, is the applicant of record for K253686.

How long did the K253686 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Mar 23, 2026, 122 days later.

← All decisions in March 2026