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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 / K261289

510(k) cleared

UNiD Spine Analyzer (SW3002)

Medicrea International S.A.S. (Medtronic) · May 15, 2026 · K261289

FDA cleared the UNiD Spine Analyzer (SW3002) from Medicrea International S.A.S. (Medtronic) on May 15, 2026 under K261289, 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 20, 2026. The decision came 25 days later, inside the 90 FDA-day goal for a 510(k).

Medicrea International S.A.S. (Medtronic) has one other decision in the tracker over the last 12 months: K253577 (IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter)).

Questions & Answers

What did FDA clear under K261289?

K261289 is the FDA 510(k) for UNiD Spine Analyzer (SW3002), submitted by Medicrea International S.A.S. (Medtronic). FDA's decision date was May 15, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the UNiD Spine Analyzer (SW3002)?

Medicrea International S.A.S. (Medtronic), based in Rillieux-La-Pape, is the applicant of record for K261289.

How long did the K261289 review take?

FDA received the submission on Apr 20, 2026 and issued its decision on May 15, 2026, 25 days later.

← All decisions in May 2026

Sources