DEVICE: FUJI IP CASSETTE CC (04547410211252)
Device Identifier (DI) Information
FUJI IP CASSETTE CC
CC BWPB 35.4X35.4cm(14X14)
In Commercial Distribution
FUJIFILM CORPORATION
CC BWPB 35.4X35.4cm(14X14)
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 | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]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. |
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 [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
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 |
---|
Device Size Text, specify: 35.4X35.4 CM |
Device Record Status
1afd05fe-b303-46c4-99b9-974078ea7b6b
March 29, 2018
2
September 16, 2016
March 29, 2018
2
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 |
---|---|---|---|---|---|
14547410211259 | 5 | 04547410211252 | In Commercial Distribution | box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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