AccessGUDID - DEVICE: 1717SGV (08800018600634)

GUDID

Device Identifier (DI) Information

Brand Name: 1717SGV
Version or Model: 1717SGV
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Rayence Co., Ltd.

Primary DI Number: 08800018600634
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557804458 *Terms of Use

Device Description: Flat Panel Detector is indicated for digital imaging solution designed for general radio graphic system for human anatomy. It is intended to replace film or screen based radio graphic systems in all general purpose diagnostic procedures. Not to be used for mammography.

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):	Yes
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?
61108	Indirect flat panel x-ray detector	An electrically-powered, cassette-like device intended to be used as part of an x-ray system to detect x-ray images following exposure, and create a digital signal; it is not dedicated to imaging of a specific anatomy. It includes two types of transducing technology (i.e., indirect): a scintillator [e.g. caesium iodide (CsI)] screen converts x-ray energy into light, followed by the conversion of light into a digital signal by photodiode array. The image data can be sent to an appropriate processing unit through a wired or wireless connection (e.g., Wi-Fi). It may be used in place of a fixed detector in x-ray imaging systems, e.g., as part of a digital imaging conversion system.	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 [?]
K201796	000

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
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Storage Environment Atmospheric Pressure: between 86 and 106 KiloPascal
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 435cc29f-6198-4431-8830-7468857019ef
Public Version Date: August 06, 2020
Public Version Number: 1
DI Record Publish Date: July 29, 2020