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Found 17 results
510(k) Data Aggregation
K Number
K241113Device Name
VIVIX-M
Manufacturer
Vieworks Co., Ltd.
Date Cleared
2025-01-16
(269 days)
Product Code
MUE
Regulation Number
892.1715Why did this record match?
Applicant Name (Manufacturer) :
Vieworks Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VIVIX-M detectors are flat panel detectors used in mammographic applications to acquire digital images for screening and diagnosis.
Device Description
VIVIX-M, a series of flat panel detectors models named; FXMD-2430S, with imaging areas of 24cm x 30cm, 18cm x 24cm, respectively. The device intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)-detectors that create electrical signals. After the electrical signals are generated, it is converted to digital value, and the Software acquires and processes the data values from the detector. The resulting digital images will be displayed on monitors. These devices should be integrated with an operating PC and an X-Ray generator. It can be utilized to digitalize x-ray images and transfer for radiography diagnostic.
VXvue Mammo is a digital X-ray imaging software designed for mammography applications. It acquires, processes, and transmits digital images from VIVIX-M detectors (FXMD-1008S and FXMD-2430S) while ensuring compliance with DICOM standards for seamless integration with PACS and other medical systems.
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K Number
K241125Device Name
VIVIX-S 1751S
Manufacturer
Vieworks Co., Ltd.
Date Cleared
2024-11-15
(206 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Vieworks Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VIVIX-S 1751S series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S 1751S series is not intended for mammography applications.
Device Description
The VIVIX-S 1751S, available in models FXRD-1751SA and FXRD-1751SB, features a 17x51 inch imaging area. This device intercepts x-ray photons and uses a scintillator to emit visible spectrum photons. The FXRD-1751SA model uses a Csl:Tl (Thallium doped Caesium lodide) scintillator, while the FXRD-1751SB model uses a Gadox (Gadolinium Oxysulfide) scintillator. These photons illuminate an array of photo (a-SI) detectors, creating electrical signals are then converted to digital values, which are processed by software to produce digital images displayed on monitors. The VIVIX-S 1751S must be integrated with an operating PC and an X-ray generator, and it can communicate with the generator via cable. It is designed for capturing and transferring digital x-ray images for radiography diagnosis. Note that the X-ray generator and imaging software are not included with the VIVIX-S 1751S.
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K Number
K220239Device Name
Solid State X-ray Imager(Model: FXRD-4386WB)
Manufacturer
Vieworks Co., Ltd.
Date Cleared
2022-09-13
(228 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Vieworks Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VIVIX-S 4386W is indicated for digital imaging solution designed as a general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purposes of diagnostic procedures. It is not to be used for mammography. It is intended for both adult and pediatric populations.
Device Description
VIVIX-S 4386W, a flat panel detector model named; FXRD-4386WB with imaging areas of 43cm x 86cm. The device intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)-detectors that create electrical signals. After the electrical signals are generated, it is converted to digital value, and the Software which acquires and processes the data values from the detector. The resulting digital images will be displayed on monitors. These devices should be integrated with an operating PC and an X-Ray generator. It can be utilized to digitalize x-ray images and transfer for radiography diagnostic.
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K Number
K221512Device Name
Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW)
Manufacturer
Vieworks Co., Ltd.
Date Cleared
2022-07-20
(57 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Vieworks Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VIVIX-S FW series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S FW series is not intended for mammography applications.
Device Description
VIVIX-S -FW, a series for of flat panel detectors models named; FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW, with imaging areas of 25cm x 30cm, 36cm x 43cm, 43cm x 43cm, respectively. The detectors can acquire static images as well as fluoroscopic images up to 6fps.
The device intercepts x-ray photons and the scintillator (Cesium lodide) emits visible spectrum photons that illuminate an array of photo (a-SI)-detectors that create electrical signals. After the electrical signals are generated, it is converted to digital value is transmitted either by wire via cable or wirelessly through a system control unit (SCU), and the software called Vxvue acquires and processes the data values from the detector. The SW is of moderate level of concern. On the Vxvue, the use can view as well as perform basic manipulations such as (rotation, enlargement, etc.) on the acquired images. These devices should be integrated with an operating PC and an X-Ray generator. It can be utilized to digitalize x-ray images and transfer for radiography diagnostic.
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K Number
K200418Device Name
VIVIX-S VW
Manufacturer
Vieworks Co., Ltd.
Date Cleared
2020-03-18
(27 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Vieworks Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VIVIX-S VW series is used for the general-purpose diagnostic procedures, and as intended to replace radiographic film/ screen systems. The VIVIX-S VW series is not intended for mammography applications.
Device Description
VIVIX-S VW, a series for of flat panel detectors models named; FXRD-2530VW, FXRD-2530VW PLUS, FXRD-3643VW, FXRD-3643VW PLUS, FXRD-4343VW, FXRD-4343VW PLUS, with imaging areas of 25cm x 30cm, 36cm x 43cm, 43cm, respectively. The device intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)-detectors that create electrical signals. After the electrical signals are generated, it is converted to digital value, and the Software which acquires and processes the data values from the detector. The resulting digital images will be displayed on monitors. These devices should be integrated with an operating PC and an X-Ray generator. It can be utilized to digitalize x-ray images and transfer for radiography diagnostic.
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K Number
K190611Device Name
VIVIX-S 1751S
Manufacturer
Vieworks Co., Ltd.
Date Cleared
2019-04-08
(28 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Vieworks Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VIVIX-S 1751S series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S 1751S series is not intended for mammography applications.
Device Description
VIVIX-S 1751S, whose model name is VIVIX-S 1751S with 17X51 inches of imaging area. The device intercepts x-ray photons, and its Gadox (Gadolinium Oxysulfide) scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)-detectors that create electrical signals. After the electrical signals are generated, it is converted to digital value, and the software acquires and processes the data values from the detector. The resulting digital images will be displayed on monitors. These devices should be integrated with an operating PC and an X-Ray generator. The detector can communicate with the generator by cable. It is utilized for capturing and transfer of digital x-ray images for radiography diagnosis. The X-ray generator and the imaging software are not part of the VIVIX-S 1751S.
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K Number
K181003Device Name
VIVIX-S 1717V
Manufacturer
Vieworks Co., Ltd.
Date Cleared
2018-05-15
(29 days)
Product Code
MQB, MOB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Vieworks Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VIVIX-S 1717V series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S 1717V series is not intended for mammography applications.
Device Description
VIVIX-S 1717V - Models FXRD-1717VA and FXRD-1717VB intercept X-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)-detectors that create an electrical signals. After the electrical signals are generated, these are converted to a digital value, and an image will be displayed on the monitor.
These devices should be integrated with an operating PC and an X-Ray generator to digitalize Xray images and transfer the digitalized images for radiography diagnostic.
Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, and image information sharing on the network.
VIVIX-S 1717V - Models FXRD-1717VA and FXRD-1717VB are digital X-ray flat panel detectors, and each model has a 17 x 17 inch imaging area.
The scintillator used in FXRD-1717VA is Csl and Gadox was used for FXRD-1717VB.
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K Number
K163703Device Name
VIVIX-S 1417N
Manufacturer
VIEWORKS CO., LTD.
Date Cleared
2017-02-08
(41 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
VIEWORKS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VIVIX-S 1417N Series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film / screen systems. The VIVIX-S 1417N Series is not intended for mammography applications.
FXRD-1417NAW and FXRD-1417NBW are indicated for digital imaging solution designed as a general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purposes of diagnostic procedures. It is not to be used for mammography.
Device Description
Models FXRD-1417NAW and FXRD-1417NBW intercept X-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)-detectors that create an electrical signals. After the electrical signals are generated, these are converted to a digital value, and an image will be displayed on the monitor.
These devices should be integrated with an operating PC and an X-Ray generator to digitalize Xray images and transfer the digitalized images for radiography diagnostic.
Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, andimage information sharing on the network.
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K Number
K161113Device Name
QXLink
Manufacturer
VIEWORKS CO., LTD.
Date Cleared
2016-08-05
(107 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
VIEWORKS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The QXLink is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components may provide functions for performing related to image manipulation, enhancement, compression or quantification. And images may be acquired from imaging devices such as CR, CT, MR and other devices. This device is not intended for mammographic operations.
Device Description
The QXLink is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. The software components may provide functions for performing related to image manipulation, enhancement, compression or quantification.
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K Number
K152855Device Name
VIVIX-S 1012N
Manufacturer
VIEWORKS CO., LTD.
Date Cleared
2016-02-26
(150 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
VIEWORKS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VIVIX-S 1012N (FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW) is indicated for digital imaging solution designed as a general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purposes of diagnostic procedures. It is not to be used for mammography.
Device Description
Models FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW intercept X-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)-detectors that create an electrical signals. After the electrical signals are generated, these are converted to a digital value, and an image will be displayed on the monitor.
These devices should be integrated with an operating PC and an X-Ray generator to digitalize Xray images and transfer the digitalized images for radiography diagnostic.
Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, and image information sharing on the network.
Ask a Question
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