VIVIX-S FW

GUDID 08809394330609

VIEWORKS CO., LTD.

Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector Indirect flat panel x-ray detector

Primary Device ID	08809394330609
NIH Device Record Key	65d81586-242c-471b-a341-b33d47a00141
Commercial Distribution Status	In Commercial Distribution
Brand Name	VIVIX-S FW
Version Model Number	FXRD-4343FAW
Company DUNS	688274778
Company Name	VIEWORKS CO., LTD.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809394330609 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K221512

FDA Product Code

MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-10-23
Device Publish Date	2023-10-13

On-Brand Devices [VIVIX-S FW]

08809394330609	FXRD-4343FAW
08809394330593	FXRD-3643FAW
08809394330586	FXRD-2530FAW