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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 / July 2026 / K260192

510(k) cleared

DIANA

ROPCA ApS · Jul 24, 2026 · K260192

FDA cleared the DIANA from ROPCA ApS on Jul 24, 2026 under K260192, 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 Jan 22, 2026. The decision came 183 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

ROPCA ApS has one other decision in the tracker over the last 12 months: K260190 (ARTHUR).

Questions & Answers

What did FDA clear under K260192?

K260192 is the FDA 510(k) for DIANA, submitted by ROPCA ApS. FDA's decision date was Jul 24, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the DIANA?

ROPCA ApS, based in Odense M, is the applicant of record for K260192.

How long did the K260192 review take?

FDA received the submission on Jan 22, 2026 and issued its decision on Jul 24, 2026, 183 days later.

← All decisions in July 2026