AccessGUDID - DEVICE: AWS-d (04547410316896)

GUDID

Device Identifier (DI) Information

Brand Name: AWS-d
Version or Model: FDR-2000AWS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FUJIFILM CORPORATION

Primary DI Number: 04547410316896
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 713565195 *Terms of Use

Device Description: FDR-2000AWS is a workstation used for Mammography System, intended to associate digital mammography images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving.

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37645	Stationary basic diagnostic x-ray system, digital	An assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.	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 [?]
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
No Device Sizes

Device Record Status

Public Device Record Key: 06374aa2-ca7c-4481-8f3c-783f0bbe9200
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 16, 2016