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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 / August 2026 / K261170

510(k) cleared

BA-004CC

Fujifilm Corporation · Aug 12, 2026 · K261170

FDA cleared the BA-004CC from Fujifilm Corporation on Aug 12, 2026 under K261170, a traditional 510(k). The device falls under product code ITX, Transducer, Ultrasonic, Diagnostic, regulated at 21 CFR 892.1570 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 9, 2026. The decision came 125 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: 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), K254075 (Synapse Lung Nodule AI).

Questions & Answers

What did FDA clear under K261170?

K261170 is the FDA 510(k) for BA-004CC, submitted by Fujifilm Corporation. FDA's decision date was Aug 12, 2026, under product code ITX (Transducer, Ultrasonic, Diagnostic).

Who makes the BA-004CC?

Fujifilm Corporation, based in Ashigara Kami-Gun, is the applicant of record for K261170.

How long did the K261170 review take?

FDA received the submission on Apr 9, 2026 and issued its decision on Aug 12, 2026, 125 days later.

← All decisions in August 2026