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510(k) Data Aggregation

    K Number
    K230985
    Device Name
    Planmeca Viso
    Manufacturer
    Planmeca Oy
    Date Cleared
    2023-12-28

    (266 days)

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

    Planmeca Oy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Planmeca Viso is a system intended to produce two-dimensional (2D) and three-dimensional (3D) digital X-ray images as well as three-dimensional (3D) optical images of the dento-maxillo-facial, cervical spine and ENT (Ear, Nose, and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
    Device Description
    The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images of the maxillofacial and ENT anatomies. Two dimensional (2D) images are produced with tomosynthesis method (panoramic) imaging) as well as conventional 2D radiography (cephalometric imaging, 2D views). In CBCT a cylindrical volume of data is captured in one imaging procedure. The data consists of several hundred sample images which are taken from different directions to cover a certain pre-programmed target area. These samples are used for 3D reconstruction (using a dedicated 3D reconstruction hardware) that can be viewed in three dimensions using separate workstation and Planmeca Romexis software.
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    K Number
    K200572
    Device Name
    Planmeca Romexis
    Manufacturer
    Planmeca Oy
    Date Cleared
    2020-12-02

    (272 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Planmeca Oy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Planmeca Romexis is a medical imaging software intental and medical care as a tool for displaying and visualizing dental and medical 2D and 3D image files from imaging devices, such as projection radiography and CBCT. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, diagnose, review, store, print, and distribute images of both adult and pediatric patients. Planmeca Romexis is also a preoperative software used for dental implant planning. Based on the plant position a model of a surgical guide for a guided implant surgery can be designed objects can be exported to manufacture a separate physical product. Planmeca Romexis is also a preoperative software for simulating surgical treatment options. Planmeca Romexis is also intended to be used for monitoring, storing and displaying mandibular jaw positions and movements relative to the maxilla. Additionally, Planmeca Romexis includes monitoring features for Planmeca devices for maintenance purposes. The software is designed to work as a stand-alone or as an accessory to Planmeca dental unit products in standard PC. The software is for use by authorized healthcare professionals. Use of the software for implant planning requires that the user has the necessary medical training in implantology and surgical dentistry. Use of the software for surgical treatment planning requires that the user has the necessary medical training in maxillofacial surgery. Indications of the dental implants do not change with guided surgery compared to conventional surgery.
    Device Description
    Planmeca Romexis is a modular imaging software for dental and medical use. It is divided into modules to provide user access to different workflow steps involving different diagnostic views of images. Patient management screen with search capabilities lets users to find patients and identify correct patient file before starting work with a patient. After creating or selecting patient, new images can be acquired using select Planmeca X-ray units. Planmeca Romexis is capable of processing and displaying 2D images in different formats and 3D CBCT images in DICOM format. 3D CBCT images can be viewed in near real-time multi projection reconstruction (MPR) views. 2D and 3D image browsers are provided to allow user access to relevant images. Typical image enhancement filters and tools are available to assist the user in making diagnosis, but original exposure is always kept in the database for reference. lmages can be exported to files or writable media, printed to paper or DICOM media or transferred securely to other users using Planmeca online services. Interfaces to select external software are provided to facilitate exchange of patient information and images or data between Software and 3rd party applications.
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    K Number
    K181576
    Device Name
    Planmeca Viso
    Manufacturer
    Planmeca Oy
    Date Cleared
    2018-09-13

    (90 days)

    Product Code
    OAS, 510
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Planmeca Oy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Planmeca Viso is a system intended to produce two-dimensional (2D) and three-dimensional (3D) digital x-ray images as well as three-dimensional (3D) optical images of the dento-maxillo-facial, cervical spine and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
    Device Description
    The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images of the maxillofacial and ENT anatomies. Two dimensional (2D) images are produced with tomosynthesis method (panoramic) imaging) as well as conventional 2D radiography (cephalometric imaging, 2D views). In CBCT a cylindrical volume of data is captured in one imaging procedure. The data consists of several hundred sample images which are taken from different directions to cover a certain pre-programmed target area. These samples are used for 3D reconstruction (using a separate 3D reconstruction PC) that can be viewed in three dimensions using separate workstation and Planmeca Romexis software.
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    K Number
    K171385
    Device Name
    Planmeca Romexis
    Manufacturer
    Planmeca Oy
    Date Cleared
    2017-11-14

    (187 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Planmeca Oy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Planmeca Romexis is a medical imaging software intended for use in dental and medical care as a tool for displaying and visualizing dental and medical 2D and 3D image files from imaging devices, such as projection radiography and CBCT. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, diagnose, review, store, print, and distribute images of both adult and pediatric patients. Planmeca Romexis is also a preoperative software application used for dental implant planning. Based on the planned implant position a model of a surgical guide for a guided implant surgery can be designed data can be exported to manufacture a separate physical product. Additionally, Planmeca Romexis includes monitoring features for Planmeca devices for maintenance purposes. The software is designed to work as a stand-alone or as an accessory to Planmeca dental unit products in a standard PC. The software is for use by authorized healthcare professionals. Use of the software for implant planning requires that the user has the necessary medical training in implantology and surgical dentistry. Indications of the dental implants do not change with guided surgery compared to conventional surgery. Planmeca Romexis is also intended to be used for monitoring, storing and displaying mandibular jaw positions and movements relative to the maxilla. This device is not indicated for mammography use.
    Device Description
    Planmeca Romexis is a modular imaging software for dental and medical use. It is divided into modules to provide user access to different workflow steps involving different diagnostic views of images. Patient management screen with search capabilities lets users to find patients and identify correct patient file before starting work with a patient. After creating or selecting patient, new images can be acquired using select Planmeca X-ray units. Planmeca Romexis is capable of processing and displaying 2D images in different formats and 3D CBCT images in DICOM format. 3D CBCT images can be viewed in near real-time multi projection reconstruction (MPR) views. 2D and 3D image browsers are provided to allow user access to relevant images. Typical image enhancement filters and tools are available to assist the user in making diagnosis but original exposure is always kept in the database for reference. Images can be exported to files or writable media, printed to paper or DICOM media or transferred securely to other users using Planmeca online services. Interfaces to select external software are provided to facilitate exchange of patient information and images or data between Software and 3rd party applications.
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    K Number
    K160506
    Device Name
    Planmeca ProMax 3D Max, Planmeca Maximity
    Manufacturer
    PLANMECA OY
    Date Cleared
    2016-05-20

    (86 days)

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

    PLANMECA OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Planmeca ProMax 3D Max or Maximity is a system intended to produce two-dimensional (2D) and three- dimensional (3D) digital X-ray images of the dento-maxillo-facial, cervical spine and ENT (Ear, Nose, and Throat) regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
    Device Description
    The Planmeca ProMax 3D Max or Planmeca Maximity -x-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images of the maxillofacial and ENT anatomies. Two dimensional (2D) images are produced with tomosynthesis method. In CBCT a cylindrical volume of data is captured in one imaging procedure. The data consists of several hundred sample images which are taken from different directions to cover a certain preprogrammed target area. These samples are used for 3D reconstruction (using a separate 3D reconstruction PC) that can be viewed in three dimensions in the Planmeca Romexis program (on a separate PC system). Ethernet computer networking technology is used.
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    K Number
    K140713
    Device Name
    PLANMECA ROMEXIS
    Manufacturer
    PLANMECA OY
    Date Cleared
    2014-06-16

    (87 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLANMECA OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Planmeca Romexis is a medical imaging software, and is intended for use in dental and medical care as a tool for displaying and visualizing dental and medical 2D and 3D image files from imaging devices, such as projection radiography and CBCT. It is intended to retrieve, process, render, diagnose, review, store, print, and distribute images. It is also a preoperative software application used for the simulation and evaluation of dental implants. The software includes monitoring features for Planmeca devices for maintenance purposes. It is designed to work as a stand-alone or as an accessory to Planmeca imaging and Planmeca dental unit products in a standard PC. The software is for use by authorized healthcare professionals. Planmeca Romexis software is: - Not intended for capturing optical impressions for dental restorations. - Not intended for optically scanning stone models and impressions for dental restorations. - Not intended for optically scanning intraoral preparations for use in designing implants and/or abutments. - Not intended for optically scanning intra-orally for use in orthodontics. - Not intended for mammography use.
    Device Description
    Planmeca Romexis is a modular imaging software for dental and medical use. It is divided into modules to provide user access to different workflow steps involving different diagnostic views of images. Patient management screen with search capabilities lets users to find patients and identify correct patient file before starting work with a patient. After creating or selecting patient, new images can be acquired using select Planmeca X-ray units. Planmeca Romexis is capable of processing and displaying 2D images in different formats and 3D CBCT images in DICOM format. 3D CBCT images can be viewed in near real-time multi projection reconstruction (MPR) views. 2D and 3D image browsers are provided to allow user access to relevant images. Typical image enhancement filters and tools are available to assist the user in making diagnosis but original exposure is always kept in the database for reference.
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    K Number
    K103689
    Device Name
    PLANMECA PROMAX 3D MID
    Manufacturer
    PLANMECA OY
    Date Cleared
    2011-03-17

    (90 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLANMECA OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Planmeca ProMax 3D Mid, is a panoramic and cephalometric x-ray unit, which uses Cone Beam Volumetric Tomography (CBVT) to produce three-dimensional images of the human teeth, jaws and skull. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. The device is to be operated and used by dentists and other legally qualified health care professionals.
    Device Description
    The Planmeca ProMax 3D Max is in principle a conventional digital panoramic/tomography xray system with three-dimensional Cone Beam Volumetric Tomography (CBVT) system add on. The product rotates around the patient and takes still images with a flat panel sensor synchronized to x-ray generator pulsing. A 3D reconstruction engine calculates the cylindrical 3-dimensional volume image, which then is viewed in 3D viewing stations.
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    K Number
    K093590
    Device Name
    PLANMECA PROMAX 3D MAX
    Manufacturer
    PLANMECA OY
    Date Cleared
    2010-05-12

    (174 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLANMECA OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Planmeca Promax 3D Max, is a three dimensional Cone Beam Volumetric Tomography (CBVT) x-ray system, which is intended to produce three-dimensional images of the human teeth, jaw and skull. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. The device is to be operated and used by dentists and other legally qualified health care professionals.
    Device Description
    The Planmeca Promax 3D Max is in principle a conventional digital panoramic/tomography xray system with three-dimensional Cone Beam Volumetric Tomography (CBVT) system add on. The product rotates around the patient and takes still images with a flat panel sensor synchronized to x-ray generator pulsing. A 3D reconstruction engine calculates the cylindrical 3-dimensional volume image, which then is viewed in 3D viewing stations.
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    K Number
    K091197
    Device Name
    PLANMECA PROSENSOR
    Manufacturer
    PLANMECA OY
    Date Cleared
    2009-07-29

    (97 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLANMECA OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Planmeca ProSensor, digital intraoral x-ray imaging system, is an accessory to dental intraoral x-ray devices. It is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device is digital, and the images are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer. The device is to be operated and used by dentists and other legally qualified professionals.
    Device Description
    The Planmeca ProSensor is an accessory to the intraoral x-ray unit, and it captures the x-ray image with a sensor placed inside the patient's mouth. The digitized image is then sent either via Ethernet or a USB connection to a computer for viewing and archiving. The system consists of a sensor, a control box and a PoE (only needed for the Ethernet version).
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    K Number
    K072244
    Device Name
    PLANMECA PROONE
    Manufacturer
    PLANMECA OY
    Date Cleared
    2007-09-21

    (39 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLANMECA OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Planmeca ProOne, dental panoramic x-ray imaging system, is an extraoral source x-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device is digital, and the images are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer. The device is to be operated and used by dentists and other legally qualified professionals.
    Device Description
    The Planmeca ProOne is a conventional panoramic x-ray system utilizing the digital imaging method. The tube head assembly and sensor rotates around the patient and takes a dental panoramic image of the patient. The product is a new model, with simple and reliable design, but with all necessary functions included. The computer is linked to the device via Ethernet.
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