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510(k) Data Aggregation

    K Number
    K972312
    Device Name
    SIEMENS ORTHOPHOS DS/DS CEPH
    Manufacturer
    SIEMENS AG
    Date Cleared
    1997-09-15

    (87 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SIEMENS ORTHOPHOS DS/DS CEPH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Orthophos DS / DS Ceph is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

    Device Description

    Not Found

    AI/ML Overview

    The provided documents are a 510(k) clearance letter and an Indications For Use statement for the Siemens Orthophos DS/DS Ceph Dental System. These documents confirm that the device has received regulatory clearance based on substantial equivalence to a predicate device. However, they do not contain any information regarding acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based solely on the provided text. The requested information is typical of a premarket approval (PMA) application or a more detailed 510(k) summary, which are not included in these documents.

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