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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 / K253825

510(k) cleared

Saige-Dx

DeepHealth, Inc. · Jun 15, 2026 · K253825

FDA cleared the Saige-Dx from DeepHealth, Inc. on Jun 15, 2026 under K253825, a traditional 510(k). The device falls under product code QDQ, Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer, regulated at 21 CFR 892.2090 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 1, 2025. The decision came 196 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: K254131 (BAC).

Questions & Answers

What did FDA clear under K253825?

K253825 is the FDA 510(k) for Saige-Dx, submitted by DeepHealth, Inc.. FDA's decision date was Jun 15, 2026, under product code QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer).

Who makes the Saige-Dx?

DeepHealth, Inc., based in Somerville, MA, is the applicant of record for K253825.

How long did the K253825 review take?

FDA received the submission on Dec 1, 2025 and issued its decision on Jun 15, 2026, 196 days later.

← All decisions in June 2026

Sources