DEVICE: FUJI IMAGING PLATE (04547410059359)

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Device Identifier (DI) Information

FUJI IMAGING PLATE
IP ST-BD 18X24CM 1 E
47410-05935
FUJIFILM CORPORATION
04547410059359
GS1
1
The Imaging Plate accurately detects X-ray information which pass through skull,chest,abdomen, bone,blood vessel, muscle,etc. with or without contrast medium. Fuji computed radiography reads the Imaging Plate, and yields diagnostic images.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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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
General-purpose radiography digital imaging system An assembly of devices that acquires and digitizes x-ray images for viewing, storage, or hard-copy printing. It is used in conjunction with conventional radiographic table systems for a variety of purposes. 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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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 18X24CM
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Device Status

In Commercial Distribution
September 23, 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
14547410059356 10 04547410059359 In Commercial Distribution box
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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
No
No CLOSE

Customer Contact

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+018002728465
xxx@xxx.xxx
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