DEVICE: XDR CLARITY (D787XDR4P10ACSZ10)

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Device Record History
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Device Identifier (DI) Information
XDR CLARITY
XDR4P10SZ1
In Commercial Distribution

CYBER MEDICAL IMAGING, INC.
D787XDR4P10ACSZ10
HIBCC

1
112029934 *Terms of Use
XDR CLARITY - Size-1 Digital Intraoral Sensor
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
44905 Dental digital imaging sensor, intraoral
An analogue device that is temporarily placed in a patient's mouth to perform routine diagnostic dental imaging procedures. It uses analogue-to-digital conversion techniques to record the absorption pattern of x-ray beams used in the diagnosis and treatment of diseases of the jaw or oral cavity structures. The device is used in combination with the x-ray source (x-ray tube) that is located outside the patient's mouth during the imaging procedure; the resulting digital image is transmitted to a monitor or workstation.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MUH System, X-Ray, Extraoral Source, Digital
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K013271 000
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Sterilization
No
Yes
Sterilization Method [?]
Liquid Chemical
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Storage and Handling

[?]
Storage and Handling
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -40 and 70 Degrees Celsius
Special Storage Condition, Specify: SAME AS HANDLING CONDITIONS
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Clinically Relevant Size

[?]
Size Type Text
Length: 36.2 Millimeter
Width: 24.2 Millimeter
Height: 5.5 Millimeter
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Device Record Status
54e7cef5-4f8e-4e3c-8b6a-2ea428aea289
May 16, 2023
1
May 08, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
888-937-9729
service@xdrradiology.com
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