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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 / K254207

510(k) cleared

AiORTA - Plan v2.0

ViTAA Medical Solutions, Inc. · Mar 30, 2026 · K254207

FDA cleared the AiORTA - Plan v2.0 from ViTAA Medical Solutions, Inc. on Mar 30, 2026 under K254207, 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 Dec 29, 2025. The decision came 91 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

ViTAA Medical Solutions, Inc. has one other decision in the tracker over the last 12 months: K250337 (AiORTA - Plan).

Questions & Answers

What did FDA clear under K254207?

K254207 is the FDA 510(k) for AiORTA - Plan v2.0, submitted by ViTAA Medical Solutions, Inc.. FDA's decision date was Mar 30, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the AiORTA - Plan v2.0?

ViTAA Medical Solutions, Inc., based in Montreal, is the applicant of record for K254207.

How long did the K254207 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Mar 30, 2026, 91 days later.

← All decisions in March 2026

Sources