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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 / March 2026 / K251793

510(k) cleared

SOTA Cloud Smart Sensor (1.5)

Sota Cloud Corp. · Mar 3, 2026 · K251793

FDA cleared the SOTA Cloud Smart Sensor (1.5) from Sota Cloud Corp. on Mar 3, 2026 under K251793, a traditional 510(k). The device falls under product code MUH, System, X-Ray, Extraoral Source, Digital, regulated at 21 CFR 872.1800 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jun 11, 2025. The decision came 265 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 Sota Cloud Corp. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251793?

K251793 is the FDA 510(k) for SOTA Cloud Smart Sensor (1.5), submitted by Sota Cloud Corp.. FDA's decision date was Mar 3, 2026, under product code MUH (System, X-Ray, Extraoral Source, Digital).

Who makes the SOTA Cloud Smart Sensor (1.5)?

Sota Cloud Corp., based in Orange, CA, is the applicant of record for K251793.

How long did the K251793 review take?

FDA received the submission on Jun 11, 2025 and issued its decision on Mar 3, 2026, 265 days later.

← All decisions in March 2026