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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 / February 2026 / K253927

510(k) cleared

LiveMedica Enterprise PACS

Live Medica, LLC · Feb 6, 2026 · K253927

FDA cleared the LiveMedica Enterprise PACS from Live Medica, LLC on Feb 6, 2026 under K253927, a traditional 510(k). The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 8, 2025. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Live Medica, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253927?

K253927 is the FDA 510(k) for LiveMedica Enterprise PACS, submitted by Live Medica, LLC. FDA's decision date was Feb 6, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the LiveMedica Enterprise PACS?

Live Medica, LLC, based in Raleigh, NC, is the applicant of record for K253927.

How long did the K253927 review take?

FDA received the submission on Dec 8, 2025 and issued its decision on Feb 6, 2026, 60 days later.

← All decisions in February 2026