DEVICE: FUJI IP CASSETTE LC (04547410343748)
Device Identifier (DI) Information
FUJI IP CASSETTE LC
LC PB 35.4X124.5
In Commercial Distribution
FUJIFILM CORPORATION
LC PB 35.4X124.5
In Commercial Distribution
FUJIFILM CORPORATION
The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.
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? |
---|---|---|---|---|
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 |
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MQB | Solid state x-ray imager (flat panel/digital imager) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K042023 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 15 and 30 Degrees Celsius |
Handling Environment Humidity: between 0 and 45 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 35.4X124.5 CM |
Device Record Status
048bf398-a4ab-4612-a13b-e7596624bca8
December 11, 2023
6
September 23, 2016
December 11, 2023
6
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 |
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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