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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 / September 2025 / K251072

510(k) cleared

Segmentron Viewer

DGNCT, LLC · Sep 9, 2025 · K251072

FDA cleared the Segmentron Viewer from DGNCT, LLC on Sep 9, 2025 under K251072, 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 Apr 7, 2025. The decision came 155 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

DGNCT, LLC has one other decision in the tracker over the last 12 months: K252934 (Diagnocat).

Questions & Answers

What did FDA clear under K251072?

K251072 is the FDA 510(k) for Segmentron Viewer, submitted by DGNCT, LLC. FDA's decision date was Sep 9, 2025, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Segmentron Viewer?

DGNCT, LLC, based in Miami, FL, is the applicant of record for K251072.

How long did the K251072 review take?

FDA received the submission on Apr 7, 2025 and issued its decision on Sep 9, 2025, 155 days later.

← All decisions in September 2025