WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / March 2026 / K253944

510(k) cleared

Data Analysis Facilitation Suite (DAFS)

Voronoi Health Analytics Incorporated · Mar 16, 2026 · K253944

FDA cleared the Data Analysis Facilitation Suite (DAFS) from Voronoi Health Analytics Incorporated on Mar 16, 2026 under K253944, 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 Dec 10, 2025. The decision came 96 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 Voronoi Health Analytics Incorporated in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253944?

K253944 is the FDA 510(k) for Data Analysis Facilitation Suite (DAFS), submitted by Voronoi Health Analytics Incorporated. FDA's decision date was Mar 16, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Data Analysis Facilitation Suite (DAFS)?

Voronoi Health Analytics Incorporated, based in Vancouver, is the applicant of record for K253944.

How long did the K253944 review take?

FDA received the submission on Dec 10, 2025 and issued its decision on Mar 16, 2026, 96 days later.

← All decisions in March 2026