510(k) K251793

SOTA Cloud Smart Sensor (1.5) by Sota Cloud Corp. — Product Code MUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2026
Date Received
June 11, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Extraoral Source, Digital
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type