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510(k) Data Aggregation

    K Number
    K211720
    Device Name
    Planmed Clarity 2D, Planmed Clarify S
    Manufacturer
    Planmed Oy
    Date Cleared
    2022-07-18

    (409 days)

    Product Code
    MUE
    Regulation Number
    892.1715
    Why did this record match?
    Applicant Name (Manufacturer) :

    Planmed Oy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Planmed Clarity 2D and S mammography units acquire digital 2D mammographic images. The Planmed Clarity 2D and S systems are intended to be used for screening and diagnosis of breast cancer. The Planmed Clarity 2D and S systems may also be used for additional diagnostic workup of the breast. Additionally, the Planmed Clarity 2D and S systems can be used to provide digital x-ray images of breast biopsy specimens.
    Device Description
    The Planmed Clarity 2D and Clarity S are Full Field Digital Mammography (FFDM) systems for generating mammographic x-ray images that can be used for screening and diagnosis of breast cancer. Planmed Clarity 2D and Clarity S utilize an amorphous silicon based digital image receptor to capture images. The receptor directly converts the incoming X-ray photons to digital image data. The workflow with Clarity 2D is controlled by the side displays/touch panels and the workflow of Clarity S is controlled from the acquisition workstation and Clarity Manager acquisition and communications software. The patient information is entered manually or received from the hospital, radiology, or mammography information systems (HIS, RIS, or MIS, respectively), as a format of modality worklist. Subsequently, the images are acquired, processed, and displayed for preview. After initial evaluation by the user, the images are either printed or transferred for soft-copy review.
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    K Number
    K213278
    Device Name
    Planmed Verity
    Manufacturer
    Planmed Oy
    Date Cleared
    2022-04-28

    (209 days)

    Product Code
    OAS, JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Planmed Oy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Planmed Verity is intended to be used for X-ray computed cone beam tomography imaging of anatomies within upper and lower extremities, head and neck.
    Device Description
    The Planmed Verity is a cone beam computed tomography x-ray system for generating 3D imaging scans of extremity, head and neck anatomies. The Planmed Verity utilizes an amorphous silicon based digital image receptor to capture digital images. The toroidal shaped gantry includes a rotating x-ray source combined with a flat panel image receptor. The scan rotation angle is less than a full circle and during the scan 300 to 400 projection images are being acquired. The receptor directly converts the incoming X-ray photons to digital image data. Projection image data is used to generate a 3D image volume of the anatomy through a reconstruction software algorithm.
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    K Number
    K192317
    Device Name
    Planmed Clarity 2D and Clarity S
    Manufacturer
    Planmed Oy
    Date Cleared
    2020-10-23

    (424 days)

    Product Code
    MUE
    Regulation Number
    892.1715
    Why did this record match?
    Applicant Name (Manufacturer) :

    Planmed Oy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Planmed Clarity 2D and Planmed Clarity S mammography units acquire digital 2D mammographic images. The Planmed Clarity 2D/S systems are intended to be used for screening and diagnosis of breast cancer. The Clarity 2D/S systems may also be used for additional diagnostic workup of the breast.
    Device Description
    The Planmed Clarity 2D and Clarity S are Full Field Digital Mammography (FFDM) systems for generating mammographic x-ray images that can be used for screening and diagnosis of breast cancer. Planmed Clarity 2D and Clarity S utilize an amorphous silicon based digital image receptor to capture images. The receptor directly converts the incoming X-ray photons to digital image data. The workflow with Clarity 2D is controlled by the side displays/touch panels and the workflow of Clarity S is controlled from the acquisition workstation and Clarity Manager acquisition and communications software. The patient information is entered manually or received from the hospital, radiology, or mammography information systems (HIS, RIS, or MIS. respectively), as a format of modality worklist. Subsequently, the images are acquired. processed, and displayed for preview. After initial evaluation by the user, the images are either printed or transferred for soft-copy review.
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    K Number
    K180918
    Device Name
    Planmed Verity
    Manufacturer
    Planmed Oy
    Date Cleared
    2018-11-30

    (235 days)

    Product Code
    OAS, JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Planmed Oy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Planmed Verity is intended to be used for X-ray computed cone beam tomography imaging of anatomies within upper and lower extremities, head and neck.
    Device Description
    The Planmed Verity is a cone beam computed tomography x-ray system for generating 3D imaging scans of extremity, head and neck anatomies. The Planmed Verity utilizes an amorphous silicon based digital image receptor to capture digital images. The receptor directly converts the incoming X-ray photons to digital image data. The workflow with Planmed Verity is controlled from the integrated acquisition workstation and Planmed Verity Manager image acquisition and communications software. The patient information is entered manually or received from the hospital. radiology, or x-ray modality information systems (HIS, RIS, or MIS, respectively), as a format of modality worklist. Subsequently, the images are acquired, processed, and displayed for preview. After initial evaluation by the operator, the images are either printed or transferred for soft-copy review.
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    K Number
    K163328
    Device Name
    Planmed Clarity
    Manufacturer
    Planmed Oy
    Date Cleared
    2017-12-28

    (395 days)

    Product Code
    MUE
    Regulation Number
    892.1715
    Why did this record match?
    Applicant Name (Manufacturer) :

    Planmed Oy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Planmed Clarity 2D mammography unit acquires digital 2D mammographic images. The Planned Clarity 2D system is intended to be used for screening and diagnosis of breast cancer. The Planmed Clarity system may also be used for additional diagnostic workup of the breast.
    Device Description
    The Planmed Clarity is a Full Field Digital Mammography (FFDM) system for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Planmed Clarity utilizes an amorphous silicon based digital image receptor to capture digital images. The receptor directly converts the incoming X-ray photons to digital image data. The workflow with Planmed Clarity is controlled from the acquisition workstation and Planmed Clarity Manager image acquisition and communications software. The patient information is entered manually or received from the hospital. radiology, or mammography information systems (HIS, RIS, or MIS, respectively), as a format of modality worklist. Subsequently, the images are acquired, processed, and displayed for preview. After initial evaluation by the user, the images are either printed or transferred for soft-copy review.
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    K Number
    K143435
    Device Name
    Planmed Verity
    Manufacturer
    PLANMED OY
    Date Cleared
    2015-05-14

    (164 days)

    Product Code
    OAS, JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLANMED OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Planmed Verity is intended to be used for X-ray computed tomography imaging of anatomies within upper and lower extremities and maxillofacial area. The device is to be operated and used by legally qualified health care professionals.
    Device Description
    Planmed Verity utilizes the CBCT (Cone Beam Computed Tomography) technology with a flat panel detector to provide high resolution volumetric images. During image acquisition the detector and X-ray tube perform a single rotation around the target of imaging, during which an amount of snapshot X-ray images are acquired. The X-ray radiation is pulsed so that it is active only when data is collected for the projection images. Before reconstruction, calibration corrections are applied to the image data. The reconstruction is then performed using a dedicated reconstruction engine and algorithm. The system is designed as a compact, stand-alone unit from which the whole imaging procedure from patient information management to image acquisition, processing and archiving can be performed. The unit provides a motorized gantry with adjustable height and tilt for the best possible extremity and maxillofacial area positioning. The construction also enables a weight-bearing option, in which the patient stands inside the gantry during image acquisition. Weight-bearing imaging of the extremity shows the anatomy under natural load.
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    K Number
    K121418
    Device Name
    PLANMED VERITY
    Manufacturer
    PLANMED OY
    Date Cleared
    2013-02-01

    (266 days)

    Product Code
    JAK
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLANMED OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Planmed Verity is intended to be used for X-ray computed tomography imaging of anatomies within upper and lower extremities. The use of Planmed Verity X-ray unit is allowed only under supervision of a health care professional.
    Device Description
    Planmed Verity utilizes the CBCT (Cone Beam Computed Tomography) technology with a flat panel detector to provide high resolution volumetric images. During image acquisition the detector and X-ray tube perform a single rotation around the target of imaging, during which an amount of snapshot X-ray images are acquired. The X-ray radiation is pulsed so that it is active only when data is collected for the projection images. Before reconstruction, calibration corrections are applied to the image data. The reconstruction is then performed using a dedicated reconstruction engine and algorithm. The system is designed as a compact, stand-alone unit from which the whole imaging procedure from patient information management to image acquisition, processing and archiving can be performed. The unit provides a motorized gantry with adjustable height and tilt for the best possible extremity positioning. The construction also enables a weight-bearing option, in which the patient stands inside the gantry during image acquisition. Weight-bearing imaging of the extremity shows the anatomy under natural load.
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    K Number
    K121963
    Device Name
    PLANMED NUANCE DIGIGUIDE
    Manufacturer
    PLANMED OY
    Date Cleared
    2012-11-21

    (139 days)

    Product Code
    MUE
    Regulation Number
    892.1715
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLANMED OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Planmed Nuance DigiGuide is an optional system for Stereotactic Biopsy. It consists of a needle guidance unit attached to Planned Nuance or Planmed Nuance Excel digital mammography X-ray units and DigiGuide software module for Nuance Manager 3 acquisition software. The system is used for needle sampling of women's breast tissues for examination. The use of Planmed Nuance DigiGuide is allowed only under supervision of a health care professional.
    Device Description
    Planmed Nuance DigiGuide is a digital biopsy imaging system. This system is compatible with Planmed Nuance and Planmed Nuance Excel FFDM X-ray units. . The Planmed Nuance DigiGuide system consists of the FFDM X-ray unit (Planmed Nuance or Planmed Nuance Excel) that is equipped with the needle guidance unit and the acquisition workstation (AWS), including a personal computer with the Nuance Manager 3 software, which is used for acquiring mammographic images, determining the lesion coordinates, and taking the biopsy.
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    K Number
    K042671
    Device Name
    PLANMED SOPHIE NUANCE CLASSIC
    Manufacturer
    PLANMED OY
    Date Cleared
    2004-11-19

    (51 days)

    Product Code
    IZH
    Regulation Number
    892.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLANMED OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Planmed Sophie Nuance Classic is a mammography x-ray system, which is intended to be used to produce radiographs of the human breast. The device can be equipped with accessories to fulfil different diagnostic needs. Spot mammography is only used in combination with stereotactic needle biopsy guidance.
    Device Description
    The Planmed Sophie Nuance Classic is a conventional mammography x-ray system utilizing films and cassettes. This product is a modification of the previous devices Planmed Sophie and Planmed Sophie Classic, where the changes made are concentrated on the lower shelf construction (with easier assembly and better serviceability), a new Flex AEC system, more modern overall design and enhanced user friendliness. The modification also serves as a base to an easy upgradeability to full field digital imaging use in the future.
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    K Number
    K021945
    Device Name
    PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)
    Manufacturer
    PLANMED OY
    Date Cleared
    2003-02-21

    (253 days)

    Product Code
    IZH
    Regulation Number
    892.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLANMED OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Planmed Sophie and Planmed Sophie Classic are Mammographic X-ray Systems, which are intended to be used to produce radiographs of the human breast. The devices can be equipped with accessories to fulfil different diagnostic needs, as spot mammography and stereotactic breast needle biopsy.
    Device Description
    Planmed Sophie and Sophie Classic (with Digispot and Cytoguide)
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