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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 / K253192

510(k) cleared

DeepXray Spina

Alpha Intelligence Manifolds, Inc. · Jun 10, 2026 · K253192

FDA cleared the DeepXray Spina from Alpha Intelligence Manifolds, Inc. on Jun 10, 2026 under K253192, a traditional 510(k). The device falls under product code SAO, Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density, regulated at 21 CFR 892.1171 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 26, 2025. The decision came 257 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 Alpha Intelligence Manifolds, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253192?

K253192 is the FDA 510(k) for DeepXray Spina, submitted by Alpha Intelligence Manifolds, Inc.. FDA's decision date was Jun 10, 2026, under product code SAO (Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density).

Who makes the DeepXray Spina?

Alpha Intelligence Manifolds, Inc., based in New Taipei City, is the applicant of record for K253192.

How long did the K253192 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Jun 10, 2026, 257 days later.

← All decisions in June 2026