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510(k) Data Aggregation

    K Number
    K251096
    Device Name
    PeekMed web
    Manufacturer
    Peek Health, S.A.
    Date Cleared
    2025-07-14

    (95 days)

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

    Peek Health, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250042
    Device Name
    PeekMed web
    Manufacturer
    Peek Health, S.A.
    Date Cleared
    2025-03-19

    (70 days)

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

    Peek Health, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the output of the planning. The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers. This medical device consists of a decision support tool for qualified healthcare professionals to quickly and efficiently perform the pre-operative planning for several surgical procedures, using medical imaging with the additional capability of planning the 2D or 3D environment. The system is designed for the medical specialties within surgery and no specific use environment is mandatory, whereas the typical use environment is a room with a computer. The patient target group is adult patients who have an injury or disability diagnosed previously. There are no other considerations for the intended patient population.
    Device Description
    PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the output of the planning. The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers. As PeekMed web is capable of representing medical images in a 2D or 3D environment, performing relevant measurements on those images, and also capable of adding templates, it then can perform a total overview of the surgery. Being software it does not interact with any part of the body of the user and/or patient.
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    K Number
    K240926
    Device Name
    PeekMed web
    Manufacturer
    Peek Health, S.A.
    Date Cleared
    2024-12-06

    (246 days)

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

    Peek Health, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the planning. The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers. This medical device consists of a decision support tool for qualified healthcare professionals to quickly and efficiently perform the pre-operative planning for several surgical procedures, using medical imaging with the additional capability of planning the 2D or 3D environment. The system is designed for the medical specialties within surgery and no specific use environment is mandatory, whereas the typical use environment is a room with a computer. The patient target group is adult patients who have an injury or disability diagnosed previously. There are no other considerations for the intended patient population.
    Device Description
    PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the output of the planning. The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers. As PeekMed web is capable of representing medical images in a 2D or 3D environment, performing relevant measurements on those images, and also capable of adding templates, it then can perform a total overview of the surgery. Being software it does not interact with any part of the body of the user and/or patient.
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    K Number
    K222767
    Device Name
    PeekMed web (v1)
    Manufacturer
    Peek Health, S.A.
    Date Cleared
    2022-12-30

    (108 days)

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

    Peek Health, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PeekMed® web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for the proper use of the system in the revision and approval of the output of the planning. The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers.
    Device Description
    PeekMed® web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients' imaging studies. Experience in usage and a clinical assessment is necessary for proper use of the system in the revision and approval of the output of the planning. The multi-platform system works with a database of digital representations related to surgical materials supplied by their manufacturers. As PeekMed® web is capable of representing the medical images in a 2D or 3D environment, performing relevant measurements on those images and also capable of adding templates, it then can perform a total overview of the surgery. Being software it does not interact with any part of the body of the user and/or patient.
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    K Number
    K182464
    Device Name
    PeekMed
    Manufacturer
    Peek Health, S.A.
    Date Cleared
    2018-10-25

    (45 days)

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

    Peek Health, S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PeekMed is a software system designed to help surgeons' specialists carry out the pre-operative planning in a prompt and efficient manner for several surgical procedures, based on their patients' imaging studies. The software imports diagnostics imaging studies such as x-rays, CT or magnetic resonance image (MRI). The import process can retrieve files from a CD ROM, a local folder or the PACS. In parallel, there is a database of digital representations related to prosthetic materials supplied by their producing companies. PeekMed allows health professional to digitally perform the surgical planning without adding any additional steps to that process. This software system requires no imaging study acquisition specification (no protocol). Experience in usage and a clinical assessment are necessary for a proper use of the software.
    Device Description
    PeekMed is a standalone software application that helps specialist doctors and surgeons to perform the pre-surgical planning for different procedures in a fast and effective way, based on the imaging studies of the patients. PeekMed is a 3D pre-operative planning software for surgery. This software system allows surgeons to plan a surgery procedure simulating various environments, from hybrid (2D/3D) to 3D or 2D environments. The software imports diagnostic imaging studies such as X-rays, Computed Tomography (CT) or Magnetic Resonance Image (MRI). The import process can retrieve files from a local folder or the Picture Archiving and Communications System (PACS) of the hospital/health center. In parallel, there is a database containing digital representations related to prosthetic materials supplied by their respective manufacturers. This offers the possibility of inserting templates of the materials to be used in the surgery in addition to the measurements, making a complete overview of the surgery. In the case of a 3D or hybrid environment, the surgeon can resort to 3D model generated from a previous imaging study on the patient and 3D digital representations of the prosthetic material to be used during surgery, i.e. screws, fixation plates or full prosthesis, deriving from several producing companies.
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