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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 / June 2026 / K253296

510(k) cleared

Digital C-ARM with 3D

Allengers Medical Systems Limited · Jun 5, 2026 · K253296

FDA cleared the Digital C-ARM with 3D from Allengers Medical Systems Limited on Jun 5, 2026 under K253296, a traditional 510(k). The device falls under product code OXO, Image-Intensified Fluoroscopic X-Ray System, Mobile, regulated at 21 CFR 892.1650 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 29, 2025. The decision came 249 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 Allengers Medical Systems Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253296?

K253296 is the FDA 510(k) for Digital C-ARM with 3D, submitted by Allengers Medical Systems Limited. FDA's decision date was Jun 5, 2026, under product code OXO (Image-Intensified Fluoroscopic X-Ray System, Mobile).

Who makes the Digital C-ARM with 3D?

Allengers Medical Systems Limited, based in Sas Nagar Mohali, is the applicant of record for K253296.

How long did the K253296 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Jun 5, 2026, 249 days later.

← All decisions in June 2026