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THE TAPE

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 / K253025

510(k) cleared

Ricoh 3D for Healthcare Bolus

Ricoh 3D For Healthcare, LLC · Apr 6, 2026 · K253025

FDA cleared the Ricoh 3D for Healthcare Bolus from Ricoh 3D For Healthcare, LLC on Apr 6, 2026 under K253025, a traditional 510(k). The device falls under product code IXI, Block, Beam-Shaping, Radiation Therapy, regulated at 21 CFR 892.5710 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 19, 2025. The decision came 199 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 Ricoh 3D For Healthcare, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253025?

K253025 is the FDA 510(k) for Ricoh 3D for Healthcare Bolus, submitted by Ricoh 3D For Healthcare, LLC. FDA's decision date was Apr 6, 2026, under product code IXI (Block, Beam-Shaping, Radiation Therapy).

Who makes the Ricoh 3D for Healthcare Bolus?

Ricoh 3D For Healthcare, LLC, based in Parma, OH, is the applicant of record for K253025.

How long did the K253025 review take?

FDA received the submission on Sep 19, 2025 and issued its decision on Apr 6, 2026, 199 days later.

← All decisions in April 2026