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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 / K250694

510(k) cleared

Scaida BrainCT-ICH (v1.0)

Mlhealth 360 · Nov 25, 2025 · K250694

FDA cleared the Scaida BrainCT-ICH (v1.0) from Mlhealth 360 on Nov 25, 2025 under K250694, 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 Mar 7, 2025. The decision came 263 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 Mlhealth 360 in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250694?

K250694 is the FDA 510(k) for Scaida BrainCT-ICH (v1.0), submitted by Mlhealth 360. FDA's decision date was Nov 25, 2025, under product code QAS (Radiological Computer-Assisted Triage And Notification Software).

Who makes the Scaida BrainCT-ICH (v1.0)?

Mlhealth 360, based in Surrey, is the applicant of record for K250694.

How long did the K250694 review take?

FDA received the submission on Mar 7, 2025 and issued its decision on Nov 25, 2025, 263 days later.

← All decisions in November 2025