VIVIX-S 4343VAW

GUDID 08809394330333

Flat Panel Detector, wireless 43cm by 43cm of size

VIEWORKS CO., LTD.

Indirect flat panel x-ray detector
Primary Device ID08809394330333
NIH Device Record Keyf33b97cb-44de-445c-90b2-e291c6d95e22
Commercial Distribution StatusIn Commercial Distribution
Brand NameVIVIX-S 4343VAW
Version Model NumberFXRD-4343VAW
Company DUNS688274778
Company NameVIEWORKS 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809394330333 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-14
Device Publish Date2020-10-06

Devices Manufactured by VIEWORKS CO., LTD.

08809394330265 - VIVIX-S 1012N2024-08-09
08809394330272 - VIVIX-S 1012N2024-08-09
08809394330388 - QXLink2024-08-09
08809394330258 - VIVIX-S 1717V2024-08-01 Solid State X-ray Imager (flat panel/digital imager)
08809394330586 - VIVIX-S FW2023-10-23
08809394330593 - VIVIX-S FW2023-10-23
08809394330609 - VIVIX-S FW2023-10-23
08809394330616 - VIVIX-S 4386W2023-10-23

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