1417WGC

GUDID 08800018600542

1417WGC is a digital X-ray flat panel detector that can acquire radiographic images of human anatomy when used with existing radiographic x-ray systems

Rayence Co., Ltd.

Indirect flat panel x-ray detector
Primary Device ID08800018600542
NIH Device Record Key5ed82b49-5116-4c4c-87db-4e21f3e936a7
Commercial Distribution StatusIn Commercial Distribution
Brand Name1417WGC
Version Model Number1417WGC
Company DUNS557804458
Company NameRayence Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS108800018600542 [Primary]

FDA Product Code

MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-07
Device Publish Date2017-07-06

On-Brand Devices [1417WGC]

088000186005421417WGC is a digital X-ray flat panel detector that can acquire radiographic images of human ana
088000186003371417WGC is a digital X-ray flat panel detector that can generate images of any part of the body.

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