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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 / May 2026 / K254075

510(k) cleared

Synapse Lung Nodule AI

Fujifilm Corporation · May 27, 2026 · K254075

FDA cleared the Synapse Lung Nodule AI from Fujifilm Corporation on May 27, 2026 under K254075, 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 Dec 18, 2025. The decision came 160 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Fujifilm Corporation has 8 other decisions in the tracker over the last 12 months: K261170 (BA-004CC), K260567 (EW10-EC02 Endoscopy Support Program), K261880 (FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01), K253137 (FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T).

Questions & Answers

What did FDA clear under K254075?

K254075 is the FDA 510(k) for Synapse Lung Nodule AI, submitted by Fujifilm Corporation. FDA's decision date was May 27, 2026, under product code OEB (Lung Computed Tomography System, Computer-Aided Detection).

Who makes the Synapse Lung Nodule AI?

Fujifilm Corporation, based in Minato-Ku, Tokyo, is the applicant of record for K254075.

How long did the K254075 review take?

FDA received the submission on Dec 18, 2025 and issued its decision on May 27, 2026, 160 days later.

← All decisions in May 2026