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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 / October 2025 / K252178

510(k) cleared

MAGENTIQ-COLO (ME-APDS)

Magentiq Eye, Ltd. · Oct 3, 2025 · K252178

FDA cleared the MAGENTIQ-COLO (ME-APDS) from Magentiq Eye, Ltd. on Oct 3, 2025 under K252178, a special 510(k). The device falls under product code QNP, Gastrointesinal Lesion Software Detection System, regulated at 21 CFR 876.1520 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jul 11, 2025. The decision came 84 days later, inside the 90 FDA-day goal for a 510(k).

Magentiq Eye, Ltd. has one other decision in the tracker over the last 12 months: K260724 (MAGENTIQ-COLO (ME-APDS)).

Questions & Answers

What did FDA clear under K252178?

K252178 is the FDA 510(k) for MAGENTIQ-COLO (ME-APDS), submitted by Magentiq Eye, Ltd.. FDA's decision date was Oct 3, 2025, under product code QNP (Gastrointesinal Lesion Software Detection System).

Who makes the MAGENTIQ-COLO (ME-APDS)?

Magentiq Eye, Ltd., based in Haifa, is the applicant of record for K252178.

How long did the K252178 review take?

FDA received the submission on Jul 11, 2025 and issued its decision on Oct 3, 2025, 84 days later.

← All decisions in October 2025

Sources