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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 / K260322

510(k) cleared

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

Mighty Oak Medical · Jun 11, 2026 · K260322

FDA cleared the Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) from Mighty Oak Medical on Jun 11, 2026 under K260322, 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 Jan 30, 2026. The decision came 132 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Mighty Oak Medical has 3 other decisions in the tracker over the last 12 months: K253472 (FIREFLY® Pedicle Screw Navigation Guide), K252103 (Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)), K251532 (Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)).

Questions & Answers

What did FDA clear under K260322?

K260322 is the FDA 510(k) for Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX), submitted by Mighty Oak Medical. FDA's decision date was Jun 11, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)?

Mighty Oak Medical, based in Englewood, CO, is the applicant of record for K260322.

How long did the K260322 review take?

FDA received the submission on Jan 30, 2026 and issued its decision on Jun 11, 2026, 132 days later.

← All decisions in June 2026

Sources