XLinearVision

GUDID 06972259248011

Shenzhen Xpectvision Technology Co.,Ltd.

Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral Dental digital imaging sensor, intraoral

• Primary Device ID: 06972259248011
• NIH Device Record Key: d0441d37-659e-4e4c-9b10-8840b85c88a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XLinearVision
• Version Model Number: XVD2530
• Company DUNS: 560445687
• Company Name: Shenzhen Xpectvision Technology Co.,Ltd.
• 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: true
• Manufacturing Date: true
• 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	06972259248011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220277

FDA Product Code

• MUH: System, X-Ray, Extraoral Source, Digital

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: 2022-08-22
• Device Publish Date: 2022-08-12

On-Brand Devices [XLinearVision]

• 06972259248011: XVD2530
• 06972259248004: XVD2121 Plus
• 06972259248035: XVH001
• 06972259248042: XVC001/XVC002/XVC003/XVC004