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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 / January 2026 / K252934

510(k) cleared

Diagnocat

DGNCT, LLC · Jan 15, 2026 · K252934

FDA cleared the Diagnocat from DGNCT, LLC on Jan 15, 2026 under K252934, a traditional 510(k). The device falls under product code MYN, Analyzer, Medical Image, regulated at 21 CFR 892.2070 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 15, 2025. The decision came 122 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: K251072 (Segmentron Viewer).

Questions & Answers

What did FDA clear under K252934?

K252934 is the FDA 510(k) for Diagnocat, submitted by DGNCT, LLC. FDA's decision date was Jan 15, 2026, under product code MYN (Analyzer, Medical Image).

Who makes the Diagnocat?

DGNCT, LLC, based in Miami, FL, is the applicant of record for K252934.

How long did the K252934 review take?

FDA received the submission on Sep 15, 2025 and issued its decision on Jan 15, 2026, 122 days later.

← All decisions in January 2026