DEVICE: X-MIND unity (D804W08000160)
Device Identifier (DI) Information
X-MIND unity
XMU BOTTOM 80 LONG SQUARE CON
In Commercial Distribution
W0800016
DE GÖTZEN SRL
XMU BOTTOM 80 LONG SQUARE CON
In Commercial Distribution
W0800016
DE GÖTZEN SRL
The X-MIND unity is an X-ray generator for dental intra-oral x-ray imaging, particularly, the X-MIND unity is an
extra-oral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of
disease of the teeth, jaw and oral structures.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
42297 | Stationary intraoral dental x-ray system, digital |
A diagnostic dental x-ray system designed for permanent fixture in one location to generate and control x-ray beams. It records the absorption pattern of x-ray beams used for general-purpose, routine, dental radiography examinations involving the diagnosis and treatment (e.g., surgical or interventional) of diseases of the teeth, jaw and oral cavity structures. The sensor is placed in the mouth, the purpose being to visualize a limited region in detail. The data is either from analogue-to-digital conversion techniques imaging or by digital imaging.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EHD | Unit, X-Ray, Extraoral With Timer |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K132378 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Atmospheric Pressure: between 85 and 106 KiloPascal |
Handling Environment Humidity: between 25 and 75 Percent (%) Relative Humidity |
Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Storage Environment Atmospheric Pressure: between 85 and 106 KiloPascal |
Storage Environment Humidity: between 25 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature: between 0 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
213f4d9d-8fb4-4144-884d-bb977f03ce4e
April 25, 2023
5
September 01, 2016
April 25, 2023
5
September 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+390331376760
imaging.italysupport@acteongroup.com
imaging.italysupport@acteongroup.com