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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 / June 2026 / K260174

510(k) cleared

PROBEAT-CR

Hitachi High-Tech Corp. · Jun 11, 2026 · K260174

FDA cleared the PROBEAT-CR from Hitachi High-Tech Corp. on Jun 11, 2026 under K260174, a traditional 510(k). The device falls under product code LHN, System, Radiation Therapy, Charged-Particle, Medical, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 21, 2026. The decision came 141 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 Hitachi High-Tech Corp. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260174?

K260174 is the FDA 510(k) for PROBEAT-CR, submitted by Hitachi High-Tech Corp.. FDA's decision date was Jun 11, 2026, under product code LHN (System, Radiation Therapy, Charged-Particle, Medical).

Who makes the PROBEAT-CR?

Hitachi High-Tech Corp., based in Kashiwa-Shi, is the applicant of record for K260174.

How long did the K260174 review take?

FDA received the submission on Jan 21, 2026 and issued its decision on Jun 11, 2026, 141 days later.

← All decisions in June 2026