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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 / DEN240071

510(k) cleared

neuropacs

Automated Imaging Diagnostics, LLC · Apr 3, 2026 · DEN240071

FDA cleared the neuropacs from Automated Imaging Diagnostics, LLC on Apr 3, 2026 under DEN240071, a direct 510(k). The device falls under product code SHO, Parkinsonian Syndrome Diagnostic Aid, regulated at 21 CFR 882.2000 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Dec 4, 2024. The decision came 485 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 Automated Imaging Diagnostics, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN240071?

DEN240071 is the FDA 510(k) for neuropacs, submitted by Automated Imaging Diagnostics, LLC. FDA's decision date was Apr 3, 2026, under product code SHO (Parkinsonian Syndrome Diagnostic Aid).

Who makes the neuropacs?

Automated Imaging Diagnostics, LLC, based in Gainesville, FL, is the applicant of record for DEN240071.

How long did the DEN240071 review take?

FDA received the submission on Dec 4, 2024 and issued its decision on Apr 3, 2026, 485 days later.

← All decisions in April 2026