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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 / May 2026 / K261405

510(k) cleared

ANDI 2.2

Imeka Solutions, Inc. · May 28, 2026 · K261405

FDA cleared the ANDI 2.2 from Imeka Solutions, Inc. on May 28, 2026 under K261405, a special 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 Apr 29, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Imeka Solutions, Inc. has one other decision in the tracker over the last 12 months: K252298 (ANDI 2.0).

Questions & Answers

What did FDA clear under K261405?

K261405 is the FDA 510(k) for ANDI 2.2, submitted by Imeka Solutions, Inc.. FDA's decision date was May 28, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the ANDI 2.2?

Imeka Solutions, Inc., based in Sherbrooke, is the applicant of record for K261405.

How long did the K261405 review take?

FDA received the submission on Apr 29, 2026 and issued its decision on May 28, 2026, 29 days later.

← All decisions in May 2026

Sources