DEVICE: D-EVO II C43 (04547410309324)
Device Identifier (DI) Information
D-EVO II C43
DR-ID 1212 SE A E
In Commercial Distribution
FUJIFILM CORPORATION
DR-ID 1212 SE A E
In Commercial Distribution
FUJIFILM CORPORATION
The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph.
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? |
---|---|---|---|---|
61109 | Diagnostic x-ray digital imaging conversion system |
An assembly of medical devices designed to convert an existing analogue x-ray system to digital (i.e., retrofit) through the acquisition and processing of digital images using existing analogue x-ray system components. As a system it consists of both: 1) a filmless cassette-size digital detector (e.g., indirect flat panel detector); and 2) additional processing/viewing hardware [e.g., a central processing unit (CPU) with integrated software and a monitor]. Following acquisition the system is intended to also process, view, and/or store patient images as part of picture archiving and communication. It does not contain the controls for the direct operation of an x-ray imaging system.
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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 [?] |
---|---|
K142003 | 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 15 and 80 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Handling Environment Temperature: between 15 and 30 Degrees Celsius |
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Temperature: between -30 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 460x460x15mm |
Device Record Status
b5ff3db8-d640-46ba-8a5f-9f7871e555f4
December 11, 2023
4
September 16, 2016
December 11, 2023
4
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 |
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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
[?]
+018002728465
xxx@xxx.xxx
xxx@xxx.xxx