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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 / May 2026 / K254131

510(k) cleared

BAC

DeepHealth, Inc. · May 21, 2026 · K254131

FDA cleared the BAC from DeepHealth, Inc. on May 21, 2026 under K254131, 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 22, 2025. The decision came 150 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

DeepHealth, Inc. has one other decision in the tracker over the last 12 months: K253825 (Saige-Dx).

Questions & Answers

What did FDA clear under K254131?

K254131 is the FDA 510(k) for BAC, submitted by DeepHealth, Inc.. FDA's decision date was May 21, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the BAC?

DeepHealth, Inc., based in Somerville, MA, is the applicant of record for K254131.

How long did the K254131 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on May 21, 2026, 150 days later.

← All decisions in May 2026

Sources