AccessGUDID - DEVICE: FUJI IMAGING PLATE (04547410059274)

GUDID

Device Identifier (DI) Information

Brand Name: FUJI IMAGING PLATE
Version or Model: IP-6 ST 35.4X43CM 1 E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 47410-05927
Company Name: FUJIFILM CORPORATION

Primary DI Number: 04547410059274
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 713565195 *Terms of Use

Device Description: 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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
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.

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

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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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 35.4X43CM

Device Record Status

Public Device Record Key: 97ba8f2a-9134-4623-99a9-6e91d87d73f8
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016