FDA.reportPublic FDA data

VIVIX-S 4386W

Primary DI
08809394330906
Brand
VIVIX-S 4386W
Company
VIEWORKS CO., LTD.
Model
FXRD-4386WA
Device description
Digital Flat Panel Detector
Published
2026-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260820000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260820000VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.2026-06-18MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809394330906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809394330906088093943309068809394330906

GMDN Terms#

Term, Definition table
TermDefinition
Indirect flat panel x-ray detectorAn electrically-powered, cassette-like device intended to be used as part of an x-ray system to detect x-ray images following exposure, and create a digital signal; it is not dedicated to imaging of a specific anatomy. It includes two types of transducing technology (i.e., indirect): a scintillator [e.g. caesium iodide (CsI)] screen converts x-ray energy into light, followed by the conversion of light into a digital signal by photodiode array. The image data can be sent to an appropriate processing unit through a wired or wireless connection (e.g., Wi-Fi). It may be used in place of a fixed detector in x-ray imaging systems, e.g., as part of a digital imaging conversion system.

Regulatory Flags#

DUNS number
688274778
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809394330241VIVIX-S 1717VFXRD-1717VA2019-05-31
08809394330289VIVIX-S 1751SFXRD-1751SB2020-03-25
08809394330258VIVIX-S 1717VFXRD-1717VB2019-05-31
08809394330357VIVIX-M 1824SFXMD-1008S2025-07-15
08809394330364VIVIX-M 2430SFXMD-2430S2025-07-15
08809394330678VIVIX-S 1751SFXRD-1751SA2025-01-23
08809394330265VIVIX-S 1012NFXRD-1012NA2024-08-01
08809394330272VIVIX-S 1012NFXRD-1012NB2024-08-01
08809394330388QXLinkQXLink2024-08-01
08809394330586VIVIX-S FWFXRD-2530FAW2023-10-13
08809394330593VIVIX-S FWFXRD-3643FAW2023-10-13
08809394330609VIVIX-S FWFXRD-4343FAW2023-10-13
08809394330616VIVIX-S 4386WFXRD-4386WB2023-10-13
08809394330296VIVIX-S 2530VAWFXRD-2530VAW2020-10-06
08809394330302VIVIX-S 2530VAW PLUSFXRD-2530VAW PLUS2020-10-06
08809394330319VIVIX-S 3643VAWFXRD-3643VAW2020-10-06
08809394330326VIVIX-S 3643VAW PLUSFXRD-3643VAW PLUS2020-10-06
08809394330333VIVIX-S 4343VAWFXRD-4343VAW2020-10-06
08809394330340VIVIX-S 4343VAW PLUSFXRD-4343VAW PLUS2020-10-06
08809394330005ViVIX-S with VXvueFXRD-1717SA2016-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
08057737122040Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08057737122057Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
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08809413811126ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
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08809365280001SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
08809365281015SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
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