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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 / February 2026 / K253578

510(k) cleared

BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device

Aidoc Medical , Ltd. · Feb 26, 2026 · K253578 · In the directory

FDA cleared the BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device from Aidoc Medical , Ltd. on Feb 26, 2026 under K253578, a traditional 510(k). The device falls under product code QAS, Radiological Computer-Assisted Triage And Notification Software, regulated at 21 CFR 892.2080 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 17, 2025. The decision came 101 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Aidoc Medical , Ltd. has 4 other decisions in the tracker over the last 12 months: K261317 (BriefCase-Triage), K251195 (BriefCase-Triage), K252970 (BriefCase-Triage: CARE Multi-triage CT Body), K253265 (BriefCase-Triage).

Questions & Answers

What did FDA clear under K253578?

K253578 is the FDA 510(k) for BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device, submitted by Aidoc Medical , Ltd.. FDA's decision date was Feb 26, 2026, under product code QAS (Radiological Computer-Assisted Triage And Notification Software).

Who makes the BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device?

Aidoc Medical , Ltd., based in Tel Aviv, is the applicant of record for K253578. The company is listed in the MedDevice Startups directory.

How long did the K253578 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Feb 26, 2026, 101 days later.

← All decisions in February 2026

Sources

In the startup directory

Aidoc

Imaging & Radiology · Tel Aviv, Israel