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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 / K253796

510(k) cleared

Lunit INSIGHT DBT (V1.2)

Lunit, Inc. · Mar 26, 2026 · K253796

FDA cleared the Lunit INSIGHT DBT (V1.2) from Lunit, Inc. on Mar 26, 2026 under K253796, a traditional 510(k). The device falls under product code QDQ, Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer, regulated at 21 CFR 892.2090 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 28, 2025. The decision came 118 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Lunit, Inc. has one other decision in the tracker over the last 12 months: K260320 (Lunit INSIGHT MMG (v1.1.10)).

Questions & Answers

What did FDA clear under K253796?

K253796 is the FDA 510(k) for Lunit INSIGHT DBT (V1.2), submitted by Lunit, Inc.. FDA's decision date was Mar 26, 2026, under product code QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer).

Who makes the Lunit INSIGHT DBT (V1.2)?

Lunit, Inc., based in Seoul, is the applicant of record for K253796.

How long did the K253796 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Mar 26, 2026, 118 days later.

← All decisions in March 2026

Sources