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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 / K254189

510(k) cleared

Synapse 3D Base Tools (V7.2)

Fujifilm Corporation · Apr 30, 2026 · K254189

FDA cleared the Synapse 3D Base Tools (V7.2) from Fujifilm Corporation on Apr 30, 2026 under K254189, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 23, 2025. The decision came 128 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 K254189?

K254189 is the FDA 510(k) for Synapse 3D Base Tools (V7.2), submitted by Fujifilm Corporation. FDA's decision date was Apr 30, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Synapse 3D Base Tools (V7.2)?

Fujifilm Corporation, based in Minato-Ku, Tokyo, is the applicant of record for K254189.

How long did the K254189 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on Apr 30, 2026, 128 days later.

← All decisions in April 2026