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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 / December 2025 / K251203

510(k) cleared

AVIEW Lung Nodule CAD

Coreline Soft Co., Ltd. · Dec 3, 2025 · K251203

FDA cleared the AVIEW Lung Nodule CAD from Coreline Soft Co., Ltd. on Dec 3, 2025 under K251203, a traditional 510(k). The device falls under product code OEB, Lung Computed Tomography System, Computer-Aided Detection, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 18, 2025. The decision came 229 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 Coreline Soft Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251203?

K251203 is the FDA 510(k) for AVIEW Lung Nodule CAD, submitted by Coreline Soft Co., Ltd.. FDA's decision date was Dec 3, 2025, under product code OEB (Lung Computed Tomography System, Computer-Aided Detection).

Who makes the AVIEW Lung Nodule CAD?

Coreline Soft Co., Ltd., based in Seoul, is the applicant of record for K251203.

How long did the K251203 review take?

FDA received the submission on Apr 18, 2025 and issued its decision on Dec 3, 2025, 229 days later.

← All decisions in December 2025