SOTA Cloud Imaging

GUDID 00860013687632

Dental Cloud Imaging Software

Sota Cloud Corp.

General-purpose dental x-ray system application software

• Primary Device ID: 00860013687632
• NIH Device Record Key: f3acd126-9e0c-42cd-b8aa-05805b077098
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOTA Cloud Imaging
• Version Model Number: 1
• Company DUNS: 118275757
• Company Name: Sota Cloud Corp.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860013687632 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210682

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-28
• Device Publish Date: 2025-05-20