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510(k) Data Aggregation

    K Number
    K970128
    Device Name
    ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA)
    Manufacturer
    PARK MEDICAL SYSTEMS, INC.
    Date Cleared
    1997-04-11

    (87 days)

    Product Code
    KPS
    Regulation Number
    892.1200
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    K081757
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use of the Dyna Camera 2 series collimator is to detect and image the distribution of high energy photons from an administered positron emitting radioactive agent in the human body. Same as predicate.

    Device Description

    Not Found

    AI/ML Overview

    This document describes the 510(k) summary for Park Medical Systems' 511 KeV collimator for their ISOCAM I and ISOCAM II nuclear imaging systems. The submission aims to demonstrate substantial equivalence to a predicate device, the Dyna camera 2 series high energy collimators, rather than proving the device meets specific acceptance criteria through a dedicated study with statistical endpoints.

    Here's a breakdown of the requested information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical trial or performance study with defined thresholds for sensitivity, specificity, etc. Instead, it presents a comparison table of technological characteristics and performance metrics against a predicate device to demonstrate substantial equivalence.

    Feature/Spec.Predicate (Dyna Camera 2 Series High Energy Collimator)Park 511 KeV Collimator (ISOCAM I/II)Acceptance Criteria (Implied by Substantial Equivalence to Predicate)
    Intended UseDetect and image the distribution of high energy photons from an administered positron emitting radioactive agent in the human body.Same as predicate.Be suitable for the same intended use.
    Physical Description:
    1) NameHigh Energy CollimatorUltra High Energy CollimatorBe a collimator for high energy imaging.
    2) No. of holes1,100 (round)7,500 (hex)Number and shape of holes is a design choice, not a direct performance criterion for equivalence.
    3) Energy Range44 - 525 KeV50 - 562 KeVOperate within a similar high-energy range.
    4) Thickness2.5 inches = 63.5 mm76 mmHave a physical thickness suitable for high-energy attenuation.
    5) Hole Size0.20 inches = 5.08 mm4 mmHole size is a design choice affecting resolution and sensitivity trade-offs.
    6) Septa thickness0.156 inches = 3.94 mm2 mmSepta thickness is a design choice affecting resolution and septal penetration.
    7) Field Size11.8 inches = 300 mm (diameter)419 mm × 566 mm (rectangular)Have a field size suitable for nuclear imaging.
    PerformanceResolutionResolutionResolution performance comparable to the predicate.
    FWHM 99mTc (surface)5.59 mmN/A
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