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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 / K252298

510(k) cleared

ANDI 2.0

Imeka Solutions, Inc. · Oct 22, 2025 · K252298

FDA cleared the ANDI 2.0 from Imeka Solutions, Inc. on Oct 22, 2025 under K252298, 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 Jul 23, 2025. The decision came 91 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Imeka Solutions, Inc. has one other decision in the tracker over the last 12 months: K261405 (ANDI 2.2).

Questions & Answers

What did FDA clear under K252298?

K252298 is the FDA 510(k) for ANDI 2.0, submitted by Imeka Solutions, Inc.. FDA's decision date was Oct 22, 2025, under product code QIH (Automated Radiological Image Processing Software).

Who makes the ANDI 2.0?

Imeka Solutions, Inc., based in Sherbrooke, is the applicant of record for K252298.

How long did the K252298 review take?

FDA received the submission on Jul 23, 2025 and issued its decision on Oct 22, 2025, 91 days later.

← All decisions in October 2025

Sources