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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 / March 2026 / K253818

510(k) cleared

Annalise Enterprise

Harrison-AI Medical Pty, Ltd. · Mar 3, 2026 · K253818

FDA cleared the Annalise Enterprise from Harrison-AI Medical Pty, Ltd. on Mar 3, 2026 under K253818, a traditional 510(k). The device falls under product code QAS, Radiological Computer-Assisted Triage And Notification Software, regulated at 21 CFR 892.2080 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 28, 2025. The decision came 95 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 Harrison-AI Medical Pty, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253818?

K253818 is the FDA 510(k) for Annalise Enterprise, submitted by Harrison-AI Medical Pty, Ltd.. FDA's decision date was Mar 3, 2026, under product code QAS (Radiological Computer-Assisted Triage And Notification Software).

Who makes the Annalise Enterprise?

Harrison-AI Medical Pty, Ltd., based in Sydney, is the applicant of record for K253818.

How long did the K253818 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Mar 3, 2026, 95 days later.

← All decisions in March 2026