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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 / July 2026 / K251952

510(k) cleared

Virasight

Virasoft Corporation · Jul 17, 2026 · K251952

FDA cleared the Virasight from Virasoft Corporation on Jul 17, 2026 under K251952, a traditional 510(k). The device falls under product code PSY, Whole Slide Imaging System, regulated at 21 CFR 864.3700 as a Class 2 device. The review panel was Pathology.

FDA logged the submission as received on Jun 25, 2025. The decision came 387 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 Virasoft Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251952?

K251952 is the FDA 510(k) for Virasight, submitted by Virasoft Corporation. FDA's decision date was Jul 17, 2026, under product code PSY (Whole Slide Imaging System).

Who makes the Virasight?

Virasoft Corporation, based in New York City, NY, is the applicant of record for K251952.

How long did the K251952 review take?

FDA received the submission on Jun 25, 2025 and issued its decision on Jul 17, 2026, 387 days later.

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