DEVICE: FUJI IMAGING PLATE (04547410059427)
Device Identifier (DI) Information
FUJI IMAGING PLATE
IP HR-BD 18X24CM 2 E
In Commercial Distribution
47410-05942
FUJIFILM CORPORATION
IP HR-BD 18X24CM 2 E
In Commercial Distribution
47410-05942
FUJIFILM CORPORATION
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
17904 | Computed radiography digital imaging scanner |
A device/device assembly 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 (computed radiography) for image viewing, storage, or hard-copy printing; it is not dedicated to dental use. It consists of an image reader/scanner and may also include an exposure unit with imaging receptor (e.g., a cassette containing a plate), or additional supportive hardware (e.g., 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.
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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 [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 18X24CM |
Device Record Status
71301c41-9d72-45dd-ad3d-5b54318f75f6
April 23, 2019
5
September 23, 2016
April 23, 2019
5
September 23, 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 |
---|---|---|---|---|---|
14547410059424 | 20 | 04547410059427 | In Commercial Distribution | box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
84547410059423
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+018002728465
xxx@xxx.xxx
xxx@xxx.xxx