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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 / K262143

510(k) cleared

ImageGrid StreamVue

Candelis, Inc. · Jul 23, 2026 · K262143

FDA cleared the ImageGrid StreamVue from Candelis, Inc. on Jul 23, 2026 under K262143, 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 25, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Candelis, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262143?

K262143 is the FDA 510(k) for ImageGrid StreamVue, submitted by Candelis, Inc.. FDA's decision date was Jul 23, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the ImageGrid StreamVue?

Candelis, Inc., based in Beverly Hills, CA, is the applicant of record for K262143.

How long did the K262143 review take?

FDA received the submission on Jun 25, 2026 and issued its decision on Jul 23, 2026, 28 days later.

← All decisions in July 2026