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510(k) Data Aggregation

    K Number
    K022275
    Device Name
    DELTA 32; DELTA 32 TACT
    Manufacturer
    INSTRUMENTARIUM CORP. IMAGING DIVISION
    Date Cleared
    2002-09-12

    (59 days)

    Product Code
    IZH
    Regulation Number
    892.1710
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K955411,K885020
    Why did this record match?
    Reference Devices :

    K955411, K885020

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

    Delta 32 and Delta 32 TACT® are intended to be used for diagnostic digital spot and 3D imaging, and optionally for digital stereotactic breast biopsy. Delta 32 and Delta 32 TACT® are intended to be used with the base mammographic system Diamond. However, a PC workstation of Delta 32 and Delta 32 TACT® can also be used as stand-alone for viewing images taken by Delta 32 and Delta 32 TACT®. The TACT® add-on provides means for digital 3D spot imaging using 2D projection images acquired with the system.

    Device Description

    Delta 32 and Delta 32 TACT® is a mammographic diagnostic digital mammography spot and 3D imaging system, which can also be used for digital stereotactic breast biopsy. The base system is the Diamond mammographic system (#K955411), on which the Delta 32 and Delta 32 TACT® is installed. The images are acquired by a CCD camera identical to our Delta 32 (#K002472). The needle guiding system is the same than previously, Cytoguide biopsy unit (#K885020). A PC workstation receives images and computes the necessary needle coordinates for Cytoguide unit. The PC also performs the optional TACT® 3D reconstruction identically to the Delta 32 TACT® system described in (#K002472). The PC workstation can also be used as stand-alone for viewing digital mammography spot and 3D images taken by Delta 32 and Delta 32 TACT®.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the Delta 32 with optional add-on TACT® device:

    Acceptance Criteria and Device Performance Study for Delta 32 with optional add-on TACT®

    The evaluation for the diagnostic use of the Delta 32 and Delta 32 TACT® was based on a clinical study comparing the subjective image quality of the digital system to screen and diagnostic film systems. The study used a Likert scale from +4 (digital image absolute better) to -4 (film image absolute better).

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state pre-defined acceptance criteria (e.g., "The average Likert score must be greater than X"). However, the performance indicated by the statistical significance (p

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