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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 / K262120

510(k) cleared

Avara Viewer

Avara Software · Jul 10, 2026 · K262120

FDA cleared the Avara Viewer from Avara Software on Jul 10, 2026 under K262120, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 23, 2026. The decision came 17 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Avara Software in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262120?

K262120 is the FDA 510(k) for Avara Viewer, submitted by Avara Software. FDA's decision date was Jul 10, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the Avara Viewer?

Avara Software, based in St Petersburg, FL, is the applicant of record for K262120.

How long did the K262120 review take?

FDA received the submission on Jun 23, 2026 and issued its decision on Jul 10, 2026, 17 days later.

← All decisions in July 2026