DEVICE: Flat Panel Fixed/Portable System (00823073004016)
Device Identifier (DI) Information
Flat Panel Fixed/Portable System
InnovaXion
In Commercial Distribution
Imaging Dynamics Company Ltd
InnovaXion
In Commercial Distribution
Imaging Dynamics Company Ltd
Flat Panel Detector
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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61108 | Indirect flat panel x-ray detector |
An electrically-powered, cassette-like device intended to be used as part of an x-ray system to detect x-ray images following exposure, and create a digital signal; it is not dedicated to imaging of a specific anatomy. It includes two types of transducing technology (i.e., indirect): a scintillator [e.g. caesium iodide (CsI)] screen converts x-ray energy into light, followed by the conversion of light into a digital signal by photodiode array. The image data can be sent to an appropriate processing unit through a wired or wireless connection (e.g., Wi-Fi). It may be used in place of a fixed detector in x-ray imaging systems, e.g., as part of a digital imaging conversion system.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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MQB | Solid state x-ray imager (flat panel/digital imager) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Storage Environment Temperature: between -10 and 55 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Length: 480 Millimeter |
Height: 15 Millimeter |
Weight: 3.8 Kilogram |
Width: 491 Millimeter |
Device Record Status
73240e60-6eee-4a2d-ae06-fc13dfd4a8c8
May 07, 2019
4
January 26, 2017
May 07, 2019
4
January 26, 2017
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
[?]
+1(403)251-9939
info@imagingdynamics.com
info@imagingdynamics.com