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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 / K261465

510(k) cleared

INDIRA CLOUD VIEWER

INDIGO TECHNOLOGIES · Jul 6, 2026 · K261465

FDA cleared the INDIRA CLOUD VIEWER from INDIGO TECHNOLOGIES on Jul 6, 2026 under K261465, a traditional 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 May 4, 2026. The decision came 63 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for INDIGO TECHNOLOGIES in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261465?

K261465 is the FDA 510(k) for INDIRA CLOUD VIEWER, submitted by INDIGO TECHNOLOGIES. FDA's decision date was Jul 6, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the INDIRA CLOUD VIEWER?

INDIGO TECHNOLOGIES, based in Bogota, is the applicant of record for K261465.

How long did the K261465 review take?

FDA received the submission on May 4, 2026 and issued its decision on Jul 6, 2026, 63 days later.

← All decisions in July 2026