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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 / April 2026 / K260320

510(k) cleared

Lunit INSIGHT MMG (v1.1.10)

Lunit, Inc. · Apr 23, 2026 · K260320

FDA cleared the Lunit INSIGHT MMG (v1.1.10) from Lunit, Inc. on Apr 23, 2026 under K260320, a special 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 Jan 30, 2026. The decision came 83 days later, inside the 90 FDA-day goal for a 510(k).

Lunit, Inc. has one other decision in the tracker over the last 12 months: K253796 (Lunit INSIGHT DBT (V1.2)).

Questions & Answers

What did FDA clear under K260320?

K260320 is the FDA 510(k) for Lunit INSIGHT MMG (v1.1.10), submitted by Lunit, Inc.. FDA's decision date was Apr 23, 2026, under product code QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer).

Who makes the Lunit INSIGHT MMG (v1.1.10)?

Lunit, Inc., based in Seoul, is the applicant of record for K260320.

How long did the K260320 review take?

FDA received the submission on Jan 30, 2026 and issued its decision on Apr 23, 2026, 83 days later.

← All decisions in April 2026

Sources