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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 / K251769

510(k) cleared

RevealAI-Lung

Precision Medical Ventures, Inc. Dba Revealdx · Jan 30, 2026 · K251769

FDA cleared the RevealAI-Lung from Precision Medical Ventures, Inc. Dba Revealdx on Jan 30, 2026 under K251769, a traditional 510(k). The device falls under product code POK, Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer, regulated at 21 CFR 892.2060 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 10, 2025. The decision came 234 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 Precision Medical Ventures, Inc. Dba Revealdx in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251769?

K251769 is the FDA 510(k) for RevealAI-Lung, submitted by Precision Medical Ventures, Inc. Dba Revealdx. FDA's decision date was Jan 30, 2026, under product code POK (Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer).

Who makes the RevealAI-Lung?

Precision Medical Ventures, Inc. Dba Revealdx, based in Seattle, WA, is the applicant of record for K251769.

How long did the K251769 review take?

FDA received the submission on Jun 10, 2025 and issued its decision on Jan 30, 2026, 234 days later.

← All decisions in January 2026