DEVICE: DR-ID 900MP (04547410306644)
Device Identifier (DI) Information
DR-ID 900MP
DR-ID 900 MP E
In Commercial Distribution
FUJIFILM CORPORATION
DR-ID 900 MP E
In Commercial Distribution
FUJIFILM CORPORATION
Supplies the power to the flat panel sensor and connects the flat panel sensor and the
control cabinet.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
37645 | Stationary basic diagnostic x-ray system, digital |
An assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MQB | Solid state x-ray imager (flat panel/digital imager) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Temperature: between -30 and 50 Degrees Celsius |
Handling Environment Temperature: between 15 and 30 Degrees Celsius |
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Handling Environment Humidity: between 15 and 80 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 464.5 x 516.7 x 18 mm |
Device Record Status
7536ff7e-351e-40e5-abb3-31bccd0bc9b8
March 29, 2018
2
September 16, 2016
March 29, 2018
2
September 16, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
+018002728465
xxx@xxx.xxx
xxx@xxx.xxx