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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 / August 2026 / K262449

510(k) cleared

AdvaView

ADVAHEALTH SOLUTIONS, LLC · Aug 14, 2026 · K262449

FDA cleared the AdvaView from ADVAHEALTH SOLUTIONS, LLC on Aug 14, 2026 under K262449, a special 510(k). 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 Jul 16, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for ADVAHEALTH SOLUTIONS, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262449?

K262449 is the FDA 510(k) for AdvaView, submitted by ADVAHEALTH SOLUTIONS, LLC. FDA's decision date was Aug 14, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the AdvaView?

ADVAHEALTH SOLUTIONS, LLC, based in Dover, DE, is the applicant of record for K262449.

How long did the K262449 review take?

FDA received the submission on Jul 16, 2026 and issued its decision on Aug 14, 2026, 29 days later.

← All decisions in August 2026