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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 / November 2025 / K253265

510(k) cleared

BriefCase-Triage

Aidoc Medical , Ltd. · Nov 6, 2025 · K253265 · In the directory

FDA cleared the BriefCase-Triage from Aidoc Medical , Ltd. on Nov 6, 2025 under K253265, a special 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 Sep 29, 2025. The decision came 38 days later, inside the 90 FDA-day goal for a 510(k).

Aidoc Medical , Ltd. has 4 other decisions in the tracker over the last 12 months: K261317 (BriefCase-Triage), K253578 (BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device), K251195 (BriefCase-Triage), K252970 (BriefCase-Triage: CARE Multi-triage CT Body).

Questions & Answers

What did FDA clear under K253265?

K253265 is the FDA 510(k) for BriefCase-Triage, submitted by Aidoc Medical , Ltd.. FDA's decision date was Nov 6, 2025, under product code QAS (Radiological Computer-Assisted Triage And Notification Software).

Who makes the BriefCase-Triage?

Aidoc Medical , Ltd., based in Tell-Aviv, is the applicant of record for K253265. The company is listed in the MedDevice Startups directory.

How long did the K253265 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Nov 6, 2025, 38 days later.

← All decisions in November 2025