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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 / K253628

510(k) cleared

Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)

Agada Medical, Ltd. · Jun 29, 2026 · K253628

FDA cleared the Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) from Agada Medical, Ltd. on Jun 29, 2026 under K253628, 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 Nov 19, 2025. The decision came 222 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 Agada Medical, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253628?

K253628 is the FDA 510(k) for Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012), submitted by Agada Medical, Ltd.. FDA's decision date was Jun 29, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)?

Agada Medical, Ltd., based in Ramat-Hasharon, is the applicant of record for K253628.

How long did the K253628 review take?

FDA received the submission on Nov 19, 2025 and issued its decision on Jun 29, 2026, 222 days later.

← All decisions in June 2026