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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 / K252634

510(k) cleared

Imagine® Enterprise Suite

Softlink International Private Limited · Jan 16, 2026 · K252634

FDA cleared the Imagine® Enterprise Suite from Softlink International Private Limited on Jan 16, 2026 under K252634, 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 Aug 20, 2025. The decision came 149 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 Softlink International Private Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252634?

K252634 is the FDA 510(k) for Imagine® Enterprise Suite, submitted by Softlink International Private Limited. FDA's decision date was Jan 16, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Imagine® Enterprise Suite?

Softlink International Private Limited, based in Aundh, is the applicant of record for K252634.

How long did the K252634 review take?

FDA received the submission on Aug 20, 2025 and issued its decision on Jan 16, 2026, 149 days later.

← All decisions in January 2026