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510(k) Data Aggregation

    K Number
    K202995
    Device Name
    X-ray Flat Panel Detectors/CareView 3600RF
    Manufacturer
    CareRay Digital Medical System Co., Ltd.
    Date Cleared
    2021-02-19

    (141 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    CareRay Digital Medical System Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CareView 3600RF detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purposic procedures. This product is not intended for mammography applications.
    Device Description
    The CareView 3600RF detector is a class of radiography X-ray flat panel detector that has an imaging area of 867.5mm×433.1mm. The detector communicates by a wired connection (Giga-bit Ethernet communication mode). The detector functions by intercepting X-ray photons. Then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. The electrical signals are then digitally converted to display an image on the monitor. The detector should be connected to a computer and X-ray generator to digitize X-ray images and transfer radiography diagnostics. The x-ray generator, an essential part of a full x-ray system, is not part of the subject medical device.
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    K Number
    K201932
    Device Name
    X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe)
    Manufacturer
    CareRay Digital Medical System Co., Ltd.
    Date Cleared
    2020-08-07

    (25 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    CareRay Digital Medical System Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CareView 1800Cwe/ CareView 1500Cwe detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.
    Device Description
    The CareView 1800Cwe/ CareView 1500Cwe detector is a class of digital X-ray flat panel detector that has an imaging area of 430mm×430mm×356mm. The detector communicates with wireless and an optional wired communication feature (Giga-bit Ethernet communication mode via connecting the power box). The detector functions by intercepting X-ray photons. Then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. The electrical signals are then digitally converted to display an image on the monitor. The detector should be connected to a computer and X-ray generator to digitize X-ray images and transfer radiography diagnostics. The x-ray generator, an essential part of a full x-ray system, is not part of the subject medical device. The software that supports the functions of the digital detector CareView 1800Cwe/ CareView 1500Cwe is unchanged from the predicate. And the API for the digital detector CareView 1800Cwe/ CareView 1500Cwe is the same as that for the predicate device. Besides, there are only minor differences between the firmware for the CareView 1800Cwe/ CareView 1500Cwe and predicate device except to support battery supply and wireless communication. Generally, CareView 1800Cwe is the same as the cleared product, CareView 1800Le except the wireless function. And CareView 1500Cwe is the same as the cleared product, CareView 1800Le except the wireless function and dimension.
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    K Number
    K193173
    Device Name
    CareView 1800Le
    Manufacturer
    CareRay Digital Medical System Co., Ltd.
    Date Cleared
    2019-12-13

    (25 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    CareRay Digital Medical System Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Care View 1800Le detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.
    Device Description
    The CareView 1800Le detector is a class of digital X-ray flat panel detector that has an imaging area of 430mm×430mm. The detector communicates by a wired connection (Giga-bit Ethernet communication mode via connecting the power box). The detector functions by intercepting X-ray photons. Then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. The electrical signals are then digitally converted to display an image on the monitor. The detector should be connected to a computer and X-ray generator to digitize X-ray images and transfer radiography diagnostics. The x-ray generator, an essential part of a full x-ray system, is not part of the subject medical device. The software that supports the functions of the digital detector CareView 1800Le is unchanged from the predicate. Generally, CareView 1800Le is the same as the cleared product, CareView 1800L except the pixel size. The pixel size of CareView 1800Le is 140 μm, while the CareView 1800L is 154 μm.
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    K Number
    K172581
    Device Name
    CareView 1800Cw X-ray Flat Panel Detectors
    Manufacturer
    CareRay Digital Medical System Co., Ltd.
    Date Cleared
    2017-09-26

    (29 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    CareRay Digital Medical System Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CareView 1800Cw detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.
    Device Description
    CareView 1800Cw is a kind of wireless, portable digital X-ray flat panel detectors which have 244 mm x 307 mm imaging area. The device communicates by not only the wireless communication but also wired communication feature (Giga-bit Ethernet communication mode by connecting the power box) optionally. The device intercepts X-ray photons and then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. After the electrical signals are generated, it is converted to a digital value and an image will be displayed on the monitor. The detector should be integrated with an operating PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic. The detector can't provide feedback to the generator to terminate the x-ray exposure.
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    K Number
    K163019
    Device Name
    CareView 750Cw/750C X-ray Flat Panel Detectors
    Manufacturer
    CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2016-12-01

    (31 days)

    Product Code
    MQB, MOB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CareView 750Cw/750C detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.
    Device Description
    CareView 750Cw/750C is a kind of wireless(750C does not have wireless, it has only wired fuction.) portable digital X-ray flat panel detectors which have 244 mm x 307 mm imaging area. The device communicates by not only the wireless communication but also wired communication feature (Giga-bit Ethernet communication mode by connecting the power box) optionally. The device intercepts X-ray photons and then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. After the electrical signals are generated, it is converted to a digital value and an image will be displayed on the monitor. The detector should be integrated with an operating PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic. The detector can't provide feedback to the generator to terminate the x-ray exposure. System Software Version is API V4.5.0 (NDT V3.5.5) that based on V4.2.0. But V4.5.0 is more powerful than old version. Please see the comparison of section 7 Technological Characteristics.
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    K Number
    K162178
    Device Name
    CareView 1500P X-ray Flat Panel Detectors
    Manufacturer
    CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2016-09-01

    (28 days)

    Product Code
    MQB, MOB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CareView 1500P detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.
    Device Description
    CareView 1500P is a kind of portable wireless digital X-ray flat panel detectors which have 434mm×355mm imaging area. The device communicates by not only the wireless communication but also wired communication feature (Giga-bit Ethernet communication mode by backup network port) optionally. The device intercepts X-ray photons and then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. After the electrical signals are generated, it is converted to a digital value and an image will be displayed on the monitor. The detector should be integrated with an operating PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic.
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    K Number
    K153492
    Device Name
    CareView 1800L
    Manufacturer
    CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2015-12-24

    (20 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CareView 1800L detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.
    Device Description
    CareView 1800L is a kind of cassette size digital X-ray flat panel detectors which have 434mm×434mm imaging area. The device communicates by wired communication feature (Giga-bit Ethernet communication mode by connecting the power box). The device intercepts X-ray photons and then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. After the electrical signals are generated, it is converted to a digital value and an image will be displayed on the monitor. The detector should be integrated with an operating PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic. Generally, CareView 1800L is the same as the cleared product, CareView 1500L except the dimension. The dimension of CareView 1800L is 460mm x 15mm, while the CareView 1500L is 384mm x 460mm x 15mm.
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    K Number
    K153058
    Device Name
    CareView 1500C/ CareView 1500L X-ray Flat Panel Detectors
    Manufacturer
    CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2015-11-10

    (20 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CareView 1500C/ CareView 1500L detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.
    Device Description
    CareView 1500C/ CareView 1500L is a kind of cassette size digital X-ray flat panel detectors which have 434mmx355mm imaging area. The device communicates by wired communication feature (Giga-bit Ethernet communication mode by connecting the power box). The device intercepts X-ray photons and then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. After the electrical signals are generated, it is converted to a digital value and an image will be displayed on the monitor. The detector should be integrated with an operating PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic.
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    K Number
    K141488
    Device Name
    CAREVIEW 1800R
    Manufacturer
    CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2015-09-08

    (460 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CareView 1800R X-ray Flat Panel Detectors is indicated for digital imaging solution designed for providing general radiographic system in all general purpose diagnostic procedures. CareView 1800R X-ray Flat Panel Detectors is a component of a digital imaging system. Properly integrated into a completed X-ray system, the digital X-ray imaging intended for medical application. This product is not intended for mammography applications and dental X-ray applications.
    Device Description
    CareView 1800R X-ray Flat Panel Detectors supports the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 43cm×43cm. The sensor plate of CareView 1800R X-ray Flat Panel Detectors is direct-deposited with Csl scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. The major function of the CareView 1800R X-ray Flat Panel Detectors detector is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This detector is the key component of DR system, enables to complete the digitalization of the medical X-ray imaging with the DR system software.
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    K Number
    K150929
    Device Name
    CareView 1500Cw X-ray Flat Panel Detectors
    Manufacturer
    CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.
    Date Cleared
    2015-08-04

    (120 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARERAY DIGITAL MEDICAL SYSTEM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CareView 1500Cw detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.
    Device Description
    CareView 1500Cw is a kind of wireless portable digital X-ray flat panel detectors which have 434mm×355mm imaging area. The device communicates by not only the wireless communication but also wired communication feature (Giga-bit Ethernet communication mode by connecting the power box) optionally. The device intercepts X-ray photons and then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. After the electrical signals are generated, it is converted to a digital value and an image will be displayed on the monitor. The detector should be integrated with an operating PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic. The detector can't provide feedback to the generator to terminate the x-ray exposure.
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