Cleared Traditional

SOTA Cloud Smart Sensor (1.5)

K251793 · Sota Cloud Corp. · Radiology

Mar 2026

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K251793 is an FDA 510(k) clearance for the SOTA Cloud Smart Sensor (1.5), a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Sota Cloud Corp. (Orange, US). The FDA issued a Cleared decision on March 3, 2026, 265 days after receiving the submission on June 11, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K251793 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 11, 2025
Decision Date	March 03, 2026
Days to Decision	265 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF