FDA.reportPublic FDA data

VIVIX-M 2430S

Primary DI
08809394330364
Brand
VIVIX-M 2430S
Company
VIEWORKS CO., LTD.
Model
FXMD-2430S
Published
2025-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MUEFull Field Digital, System, X-Ray, Mammographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUEFull Field Digital, System, X-Ray, MammographicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241113000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241113000VIVIX-MVieworks Co., Ltd.2025-01-16MUE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809394330364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809394330364088093943303648809394330364

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.

Sterilization Methods#

Method table
Method

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
08809394330241VIVIX-S 1717VFXRD-1717VA2019-05-31
08809394330289VIVIX-S 1751SFXRD-1751SB2020-03-25
08809394330258VIVIX-S 1717VFXRD-1717VB2019-05-31
08809394330357VIVIX-M 1824SFXMD-1008S2025-07-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08052405210203SERENYS DRMETALTRONICA SPAMUE2026-05-25
08052405210050HELIANTHUSMETALTRONICA SPAMUE2026-03-24
00198953109281Senographe PristinaGE MEDICAL SYSTEMSMUE2025-12-01
10198953054311not applicableGE MEDICAL SYSTEMSMUE2025-11-28
08809244065088GenorayGENORAY CO., LTD.MUE2025-07-24
15420045517851Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517882Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517899Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517905Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517912Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517929Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517936Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517943Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517950Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517967Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517974Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517981Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
15420045517998Selenia® Dimensions®Hologic, Inc.MUE2025-07-17
08809394330357VIVIX-M 1824SVIEWORKS CO., LTD.MUE2025-07-15
088000186022562430TCARayence Co., Ltd.MUE2025-04-08
00195278914026Senographe PristinaGE MEDICAL SYSTEMSMUE2025-01-09
10195278901764Not ApplicableGE MEDICAL SYSTEMSMUE2025-01-09
00195278866899not applicableGE MEDICAL SYSTEMSMUE2024-06-07
04056869987187MAMMOMAT B.brilliantSiemens Healthcare GmbHMUE2024-04-20
00195278719812not applicableGE MEDICAL SYSTEMSMUE2024-04-11
00195278795724not applicableGE MEDICAL SYSTEMSMUE2024-01-22
00195278711229not applicableGE MEDICAL SYSTEMSMUE2023-09-14
00195278655141not applicableGE MEDICAL SYSTEMSMUE2023-07-28
00195278661999Senographe PristinaGE MEDICAL SYSTEMSMUE2023-07-28
00195278665379Senographe PristinaGE MEDICAL SYSTEMSMUE2023-07-28