DEVICE: i-Dixel (04548213025299)
Device Identifier (DI) Information
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? |
---|---|---|---|---|
40866 | Basic diagnostic x-ray system application software |
An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose x-ray imaging system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routine packages must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LLZ | System, Image Processing, Radiological |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K073704 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity |
Handling Environment Temperature: between 10 and 35 Degrees Celsius |
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity |
Storage Environment Temperature: between -40 and 65 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
817776e0-6bee-40df-a634-2d88c6ec3887
July 06, 2018
3
September 23, 2016
July 06, 2018
3
September 23, 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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined