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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 / September 2025 / K251987

510(k) cleared

Rapid Aortic Measurements

Ischemaview, Inc. · Sep 23, 2025 · K251987

FDA cleared the Rapid Aortic Measurements from Ischemaview, Inc. on Sep 23, 2025 under K251987, 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 Jun 27, 2025. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

Ischemaview, Inc. has one other decision in the tracker over the last 12 months: K261085 (Rapid Vessel Occlusion (Rapid VO)).

Questions & Answers

What did FDA clear under K251987?

K251987 is the FDA 510(k) for Rapid Aortic Measurements, submitted by Ischemaview, Inc.. FDA's decision date was Sep 23, 2025, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Rapid Aortic Measurements?

Ischemaview, Inc., based in Golden, CO, is the applicant of record for K251987.

How long did the K251987 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Sep 23, 2025, 88 days later.

← All decisions in September 2025

Sources