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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 / January 2026 / K251934

510(k) cleared

qXR-Detect

Qure.Ai Technologies · Jan 16, 2026 · K251934

FDA cleared the qXR-Detect from Qure.Ai Technologies on Jan 16, 2026 under K251934, a traditional 510(k). The device falls under product code MYN, Analyzer, Medical Image, regulated at 21 CFR 892.2070 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 24, 2025. The decision came 206 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: K251610 (qER-CTA (v1.0)).

Questions & Answers

What did FDA clear under K251934?

K251934 is the FDA 510(k) for qXR-Detect, submitted by Qure.Ai Technologies. FDA's decision date was Jan 16, 2026, under product code MYN (Analyzer, Medical Image).

Who makes the qXR-Detect?

Qure.Ai Technologies, based in Mumbai, is the applicant of record for K251934.

How long did the K251934 review take?

FDA received the submission on Jun 24, 2025 and issued its decision on Jan 16, 2026, 206 days later.

← All decisions in January 2026