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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 / June 2026 / K261122

510(k) cleared

MIST IC

Imagine Milling Technologies, LLC · Jun 27, 2026 · K261122

FDA cleared the MIST IC from Imagine Milling Technologies, LLC on Jun 27, 2026 under K261122, a traditional 510(k). The device falls under product code NHA, Abutment, Implant, Dental, Endosseous, regulated at 21 CFR 872.3630 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Apr 3, 2026. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Imagine Milling Technologies, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261122?

K261122 is the FDA 510(k) for MIST IC, submitted by Imagine Milling Technologies, LLC. FDA's decision date was Jun 27, 2026, under product code NHA (Abutment, Implant, Dental, Endosseous).

Who makes the MIST IC?

Imagine Milling Technologies, LLC, based in Chantilly, VA, is the applicant of record for K261122.

How long did the K261122 review take?

FDA received the submission on Apr 3, 2026 and issued its decision on Jun 27, 2026, 85 days later.

← All decisions in June 2026