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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 / April 2026 / K254015

510(k) cleared

CoLumbo C-Spine

Smart Soft Healthcare AD · Apr 1, 2026 · K254015

FDA cleared the CoLumbo C-Spine from Smart Soft Healthcare AD on Apr 1, 2026 under K254015, 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 Dec 15, 2025. The decision came 107 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Smart Soft Healthcare AD in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254015?

K254015 is the FDA 510(k) for CoLumbo C-Spine, submitted by Smart Soft Healthcare AD. FDA's decision date was Apr 1, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the CoLumbo C-Spine?

Smart Soft Healthcare AD, based in Varna, is the applicant of record for K254015.

How long did the K254015 review take?

FDA received the submission on Dec 15, 2025 and issued its decision on Apr 1, 2026, 107 days later.

← All decisions in April 2026