Cliosoft

GUDID 00851159007026

SOTA PRECISION OPTICS, INC.

Stationary intraoral dental x-ray system, digital

• Primary Device ID: 00851159007026
• NIH Device Record Key: cb01e74b-a7fc-4dac-bb9a-56cb3ce31630
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cliosoft
• Version Model Number: Version 2
• Company DUNS: 601005523
• Company Name: SOTA PRECISION OPTICS, INC.
• 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: true
• 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

Customer Support Contacts

• Phone: 714-532-6100
• Email: info@sotaimaging.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851159007026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110886

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-26
• Device Publish Date: 2016-09-22

Devices Manufactured by SOTA PRECISION OPTICS, INC.

• 00851159007101 - Clio Prime: 2021-01-29
• 00851159007118 - Clio Prime: 2021-01-29
• 00851159007002 - Clio: 2018-11-26
• 00851159007019 - Clio: 2018-11-26
• 00851159007026 - Cliosoft: 2018-11-26
• 00851159007026 - Cliosoft: 2018-11-26