DEVICE: FCR XL-2 (04547410250459)

Device Identifier (DI) Information

FCR XL-2
CR-IR 359
In Commercial Distribution

FUJIFILM CORPORATION
04547410250459
GS1

1
713565195 *Terms of Use
The FCR XL-2/FCR Aspire CRm (CR-IR 359) is equipment designed to read X-ray image information recorded on an imaging plate (IP).
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Computed radiography scanning system An assembly of devices designed to be used with an analogue x-ray system to capture radiographic images and then generate digital x-ray images from them as part of a two-step process for image viewing, storage, or hard-copy printing. It typically consists of an exposure unit with imaging receptor (e.g., a cassette containing a plate), an image reader, a computer console, and a printer. The image is acquired on a photostimulatable substance (e.g., a phosphor screen mounted on a cassette plate) and converted into an electrical analogue signal in a laser scanner; this signal is in turn amplified and converted to a digital signal, which is stored and processed by a computer.
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FDA Product Code

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Product Code Product Code Name
MQB Solid state x-ray imager (flat panel/digital imager)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between -10 and 50 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Atmospheric Pressure: between 75 and 106 KiloPascal
Handling Environment Humidity: between 15 and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 75 and 106 KiloPascal
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

75b13ef0-0d64-42c2-ad3d-7e33c652e99d
February 21, 2019
3
September 16, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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+018002728465
xxx@xxx.xxx
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