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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 / July 2026 / K261085

510(k) cleared

Rapid Vessel Occlusion (Rapid VO)

iSchemaview · Jul 13, 2026 · K261085

FDA cleared the Rapid Vessel Occlusion (Rapid VO) from iSchemaview on Jul 13, 2026 under K261085, a traditional 510(k). The device falls under product code QAS, Radiological Computer-Assisted Triage And Notification Software, regulated at 21 CFR 892.2080 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 1, 2026. The decision came 103 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

iSchemaview has one other decision in the tracker over the last 12 months: K251987 (Rapid Aortic Measurements).

Questions & Answers

What did FDA clear under K261085?

K261085 is the FDA 510(k) for Rapid Vessel Occlusion (Rapid VO), submitted by iSchemaview. FDA's decision date was Jul 13, 2026, under product code QAS (Radiological Computer-Assisted Triage And Notification Software).

Who makes the Rapid Vessel Occlusion (Rapid VO)?

iSchemaview, based in Golden, CO, is the applicant of record for K261085.

How long did the K261085 review take?

FDA received the submission on Apr 1, 2026 and issued its decision on Jul 13, 2026, 103 days later.

← All decisions in July 2026

Sources