FDA.reportPublic FDA data

VIVIX-S 1717V

Primary DI
08809394330241
Brand
VIVIX-S 1717V
Company
VIEWORKS CO., LTD.
Model
FXRD-1717VA
Device description
Solid State X-ray Imager (Flat panel/ digital imager)
Published
2019-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K181003000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181003000VIVIX-S 1717VVieworks Co., Ltd.2018-05-15MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809394330241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809394330241088093943302418809394330241

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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
08809394330036ViVIX-S wiht VXvueFXRD-1717SB2016-07-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.MQB2026-04-30
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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08800011150112DRGEMDRGEM CorporationMQB2025-08-26
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D0031000086390SchickDentsply International Inc.MQB2024-11-06
D0031000086410SchickDentsply International Inc.MQB2024-11-06
D0031000086520SchickDentsply International Inc.MQB2024-11-06
D0031000086530SchickDentsply International Inc.MQB2024-11-06
D0031000086540SchickDentsply International Inc.MQB2024-11-06