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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 / K252091

510(k) cleared

Surgical Reality Viewer

Medicalvr B.V. · Jan 29, 2026 · K252091

FDA cleared the Surgical Reality Viewer from Medicalvr B.V. on Jan 29, 2026 under K252091, 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 Jul 3, 2025. The decision came 210 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 Medicalvr B.V. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252091?

K252091 is the FDA 510(k) for Surgical Reality Viewer, submitted by Medicalvr B.V.. FDA's decision date was Jan 29, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Surgical Reality Viewer?

Medicalvr B.V., based in Nieuw-Vennep, is the applicant of record for K252091.

How long did the K252091 review take?

FDA received the submission on Jul 3, 2025 and issued its decision on Jan 29, 2026, 210 days later.

← All decisions in January 2026