XLinearVision

GUDID 06972259248011

Shenzhen Xpectvision Technology Co.,Ltd.

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