1417WCC

GUDID 08800018600559

1417WCC 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 ID08800018600559
NIH Device Record Keyff820b32-51f7-460f-a8d2-52b8b8979399
Commercial Distribution StatusIn Commercial Distribution
Brand Name1417WCC
Version Model Number1417WCC
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
GS108800018600559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number5
Public Version Date2020-03-16
Device Publish Date2017-07-06

On-Brand Devices [1417WCC]

088000186005591417WCC is a digital X-ray flat panel detector that can acquire radiographic images of human ana
088000186003441417WCC is a digital X-ray flat panel detector that can generate images of any part of the body.

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