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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 / September 2025 / K251610

510(k) cleared

qER-CTA (v1.0)

Qure.Ai Technologies · Sep 8, 2025 · K251610

FDA cleared the qER-CTA (v1.0) from Qure.Ai Technologies on Sep 8, 2025 under K251610, 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 May 27, 2025. The decision came 104 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Qure.Ai Technologies has one other decision in the tracker over the last 12 months: K251934 (qXR-Detect).

Questions & Answers

What did FDA clear under K251610?

K251610 is the FDA 510(k) for qER-CTA (v1.0), submitted by Qure.Ai Technologies. FDA's decision date was Sep 8, 2025, under product code QAS (Radiological Computer-Assisted Triage And Notification Software).

Who makes the qER-CTA (v1.0)?

Qure.Ai Technologies, based in Mumbai, is the applicant of record for K251610.

How long did the K251610 review take?

FDA received the submission on May 27, 2025 and issued its decision on Sep 8, 2025, 104 days later.

← All decisions in September 2025

Sources