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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 / K253784

510(k) cleared

3DICOM MD Cloud

Singular Health Pty, Ltd. · Jan 8, 2026 · K253784

FDA cleared the 3DICOM MD Cloud from Singular Health Pty, Ltd. on Jan 8, 2026 under K253784, 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 Nov 26, 2025. The decision came 43 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Singular Health Pty, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253784?

K253784 is the FDA 510(k) for 3DICOM MD Cloud, submitted by Singular Health Pty, Ltd.. FDA's decision date was Jan 8, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the 3DICOM MD Cloud?

Singular Health Pty, Ltd., based in Leederville, is the applicant of record for K253784.

How long did the K253784 review take?

FDA received the submission on Nov 26, 2025 and issued its decision on Jan 8, 2026, 43 days later.

← All decisions in January 2026