ViVIX-S wiht VXvue

GUDID 08809394330036

VIEWORKS CO., LTD.

Indirect flat panel x-ray detector
Primary Device ID08809394330036
NIH Device Record Key77d83be0-59c1-42d4-b320-7d7373ca6102
Commercial Distribution Discontinuation2020-01-01
Commercial Distribution StatusIn Commercial Distribution
Brand NameViVIX-S wiht VXvue
Version Model NumberFXRD-1717SB
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809394330036 [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 Date2019-05-07
Device Publish Date2016-07-08

Devices Manufactured by VIEWORKS CO., LTD.

08809394330586 - VIVIX-S FW2023-10-23
08809394330593 - VIVIX-S FW2023-10-23
08809394330609 - VIVIX-S FW2023-10-23
08809394330616 - VIVIX-S 4386W2023-10-23
08809394330296 - VIVIX-S 2530VAW2020-10-14 Flat Panel Detector of 25 cm by 30 cm size. Wireless
08809394330302 - VIVIX-S 2530VAW PLUS2020-10-14 Flat Panel Detector, wireless 25cm by 30 cm of size
08809394330319 - VIVIX-S 3643VAW2020-10-14 Flat Panel Detector, wireless 36cm by 43 cm of size
08809394330326 - VIVIX-S 3643VAW PLUS2020-10-14 Flat Panel Detector, wireless 36cm by 43 cm of size

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