XpectVision

GUDID 06972259248028

Shenzhen Xpectvision Technology Co.,Ltd.

Hand-held intraoral dental x-ray system, digital

• Primary Device ID: 06972259248028
• NIH Device Record Key: fbc03987-f8a5-42b7-b911-8af9c509db44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XpectVision
• Version Model Number: XVbeam2000
• 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: true
• 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	06972259248028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233914

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

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: 2024-02-29
• Device Publish Date: 2024-02-21

Devices Manufactured by Shenzhen Xpectvision Technology Co.,Ltd.

• 06972259248028 - XpectVision: 2024-02-29
• 06972259248028 - XpectVision: 2024-02-29
• 06972259248042 - XLinearVision: 2022-11-21
• 06972259248035 - XLinearVision: 2022-11-18
• 06972259248004 - XLinearVision: 2022-08-22
• 06972259248011 - XLinearVision: 2022-08-22