XDR CLARITY

GUDID D787XDR4P10ACSZ10

XDR CLARITY - Size-1 Digital Intraoral Sensor

CYBER MEDICAL IMAGING, INC.

Dental digital imaging sensor, intraoral

• Primary Device ID: D787XDR4P10ACSZ10
• NIH Device Record Key: 54e7cef5-4f8e-4e3c-8b6a-2ea428aea289
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XDR CLARITY
• Version Model Number: XDR4P10SZ1
• Company DUNS: 112029934
• Company Name: CYBER MEDICAL IMAGING, 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-937-9729
• Email: service@xdrradiology.com
• Phone: 888-937-9729
• Email: service@xdrradiology.com
• Phone: 888-937-9729
• Email: service@xdrradiology.com
• Phone: 888-937-9729
• Email: service@xdrradiology.com
• Phone: 888-937-9729
• Email: service@xdrradiology.com
• Phone: 888-937-9729
• Email: service@xdrradiology.com
• Phone: 888-937-9729
• Email: service@xdrradiology.com
• Phone: 888-937-9729
• Email: service@xdrradiology.com
• Phone: 888-937-9729
• Email: service@xdrradiology.com
• Phone: 888-937-9729
• Email: service@xdrradiology.com
• Phone: 888-937-9729
• Email: service@xdrradiology.com
• Phone: 888-937-9729
• Email: service@xdrradiology.com
• Phone: 888-937-9729
• Email: service@xdrradiology.com
• Phone: 888-937-9729
• Email: service@xdrradiology.com
• Phone: 888-937-9729
• Email: service@xdrradiology.com
• Phone: 888-937-9729
• Email: service@xdrradiology.com
• Phone: 888-937-9729
• Email: service@xdrradiology.com

Device Dimensions

• Length: 36.2 Millimeter
• Width: 24.2 Millimeter
• Height: 5.5 Millimeter
• Length: 36.2 Millimeter
• Width: 24.2 Millimeter
• Height: 5.5 Millimeter
• Length: 36.2 Millimeter
• Width: 24.2 Millimeter
• Height: 5.5 Millimeter
• Length: 36.2 Millimeter
• Width: 24.2 Millimeter
• Height: 5.5 Millimeter
• Length: 36.2 Millimeter
• Width: 24.2 Millimeter
• Height: 5.5 Millimeter
• Length: 36.2 Millimeter
• Width: 24.2 Millimeter
• Height: 5.5 Millimeter
• Length: 36.2 Millimeter
• Width: 24.2 Millimeter
• Height: 5.5 Millimeter
• Length: 36.2 Millimeter
• Width: 24.2 Millimeter
• Height: 5.5 Millimeter
• Length: 36.2 Millimeter
• Width: 24.2 Millimeter
• Height: 5.5 Millimeter
• Length: 36.2 Millimeter
• Width: 24.2 Millimeter
• Height: 5.5 Millimeter
• Length: 36.2 Millimeter
• Width: 24.2 Millimeter
• Height: 5.5 Millimeter
• Length: 36.2 Millimeter
• Width: 24.2 Millimeter
• Height: 5.5 Millimeter
• Length: 36.2 Millimeter
• Width: 24.2 Millimeter
• Height: 5.5 Millimeter
• Length: 36.2 Millimeter
• Width: 24.2 Millimeter
• Height: 5.5 Millimeter
• Length: 36.2 Millimeter
• Width: 24.2 Millimeter
• Height: 5.5 Millimeter
• Length: 36.2 Millimeter
• Width: 24.2 Millimeter
• Height: 5.5 Millimeter
• Length: 36.2 Millimeter
• Width: 24.2 Millimeter
• Height: 5.5 Millimeter

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *SAME AS HANDLING CONDITIONS
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *SAME AS HANDLING CONDITIONS
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *SAME AS HANDLING CONDITIONS
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *SAME AS HANDLING CONDITIONS
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *SAME AS HANDLING CONDITIONS
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *SAME AS HANDLING CONDITIONS
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *SAME AS HANDLING CONDITIONS
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *SAME AS HANDLING CONDITIONS
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *SAME AS HANDLING CONDITIONS
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *SAME AS HANDLING CONDITIONS
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *SAME AS HANDLING CONDITIONS
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *SAME AS HANDLING CONDITIONS
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *SAME AS HANDLING CONDITIONS
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *SAME AS HANDLING CONDITIONS
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *SAME AS HANDLING CONDITIONS
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *SAME AS HANDLING CONDITIONS
• Handling Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *SAME AS HANDLING CONDITIONS

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D787XDR4P10ACSZ10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013271

FDA Product Code

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

Sterilization

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

[D787XDR4P10ACSZ10]

Liquid Chemical

[D787XDR4P10ACSZ10]

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[D787XDR4P10ACSZ10]

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[D787XDR4P10ACSZ10]

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[D787XDR4P10ACSZ10]

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[D787XDR4P10ACSZ10]

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[D787XDR4P10ACSZ10]

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[D787XDR4P10ACSZ10]

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[D787XDR4P10ACSZ10]

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[D787XDR4P10ACSZ10]

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[D787XDR4P10ACSZ10]

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[D787XDR4P10ACSZ10]

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[D787XDR4P10ACSZ10]

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[D787XDR4P10ACSZ10]

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[D787XDR4P10ACSZ10]

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[D787XDR4P10ACSZ10]

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[D787XDR4P10ACSZ10]

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Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-16
• Device Publish Date: 2023-05-08

On-Brand Devices [XDR CLARITY]

• D787XDR4P20ADSZ20: XDR CLARITY - Size-2 Digital Intraoral Sensor
• D787XDR4P10ACSZ10: XDR CLARITY - Size-1 Digital Intraoral Sensor