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510(k) Data Aggregation

    K Number
    K993574
    Date Cleared
    2000-01-18

    (89 days)

    Product Code
    Regulation Number
    892.1000
    Reference & Predicate Devices
    Why did this record match?
    Reference Devices :

    K962933, K983110, K962138, K946244/A1, K933018/S1

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

    Imaging of: The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan and Cine Imaging.] -Fluid Visualization -2D/3D Imaging Additional indications for v3.1, v3.2, & v3.3 (only) - MR Angiography/MR Vascular Imaging - Additional indication for v3.2 & v3.3 (only) - Water/Fat Imaging - Additional indication for v3.3 {only} Perfusion/Diffusion Imaging -

    Device Description

    Versions v3.0/v3.1/v3.2/v3.3 software are a combination of modifications and the addition of new sequences to the existing software, which facilitate the acquisition and reconstruction of MR images. The four versions have the same base software features with certain additional features available in each subsequent version (see Comparison Table, Appendix B, for detailed description). A brief description follows: - v3.0: Based on v2.5 (K990260) with MR Angio and FASE sequences removed - v3.1: Based on v2.5 (K990260) - v3.2: Based on v2.6 (K990260) - v3.3: Based on v2.6 (K990260) with addition of Perfusion/Diffusion imaging

    AI/ML Overview

    This 510(k) premarket notification describes an upgrade to an existing Magnetic Resonance Diagnostic Device, the OPART™ (Model MRT-600), to software versions v3.0, v3.1, v3.2, and v3.3, along with optional hardware items. The core of this submission is to demonstrate substantial equivalence to previously cleared versions and to justify new functionalities and increased safety parameters.

    Here's an analysis based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The submission focuses on safety parameters and imaging performance. The "acceptance criteria" appear to be specified maximums for safety and a general "specification volume" for imaging. The "reported device performance" is essentially that the device operates within these stated limits and produces sample images.

    ParameterAcceptance CriteriaReported Device Performance
    Maximum static magnetic field strengthSpecified (0.35 Tesla)0.35 Tesla (inherent to the device model)
    Rate of change of magnetic fieldSpecified (19 T/second)19 T/second (inherent to the device model)
    Maximum radio frequency power deposition (SAR)
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    K Number
    K983110
    Date Cleared
    1999-02-25

    (174 days)

    Product Code
    Regulation Number
    892.1000
    Reference & Predicate Devices
    Why did this record match?
    Reference Devices :

    K973799, K962138

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

    Imaging of:

    • The Whole Body (including head, abdomen, breast, heart, pelvis, joints, neck, TMJ, spine, blood vessels, limbs, and extremities). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynamic Scan, Cine Imaging, and Cardiac tagging.]
    • Fluid Visualization
    • 2D/3D Imaging
    • MR Angiography/MR Vascular Imaging
    • Blood Oxygenation Level Dependent (BOLD) Imaging
    Device Description

    This submission consists of a software upgrade to the MRT-50GP/E2 (FLEXARTTM), MRT-50GP/H2 (FLEXARTTM/Hyper), MRT-150/F1 (VISARTTM), MRT-150/F2 (VISARTTM/Hyper)

    AI/ML Overview

    Here's an analysis of the provided 510(k) summary relating to acceptance criteria and the study conducted:

    Disclaimer: The provided document (K983110) is a 510(k) Premarket Notification summary from 1998 for a software upgrade to existing Magnetic Resonance Diagnostic Devices (FLEXART™ and VISART™). It focuses on demonstrating substantial equivalence to previously cleared devices. It primarily discusses safety parameters and imaging performance specifications rather than a typical clinical study with acceptance criteria for a new AI/CAD device.

    This document predates widespread AI in medical imaging and the standard AI/CAD study structure. Therefore, many of the requested fields (like sample size for test/training sets, ground truth establishment methods, MRMC studies, effect sizes, and standalone performance) are not directly addressed in the provided text as they pertain to a different type of device evaluation.


    1. Table of Acceptance Criteria and Reported Device Performance

    Given the nature of the document, the "acceptance criteria" are more akin to specifications that the software upgrade maintains, and the "reported device performance" indicates that these specifications are met or comparable to the predicate devices.

    Parameter/CriteriaAcceptance Criteria (V3.5 s/w)Reported Device Performance (V4.0 s/w)Outcome/Met?
    Safety Parameters
    Maximum static field strength (FLEXART™)0.5 T0.5 TMet
    Maximum static field strength (VISART™)1.5 T1.5 TMet
    Rate of change of magnetic field (FLEXART™)11 T/sec.11 T/sec.Met
    Rate of change of magnetic field (FLEXART™/Hyper)13.3 T/sec.13.3 T/sec.Met
    Rate of change of magnetic field (VISART™)13.3 T/sec.13.3 T/sec.Met
    Rate of change of magnetic field (VISART™/Hyper)19.5 T/sec.19.5 T/sec.Met
    Maximum RF power deposition (FLEXART™)
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    K Number
    K964608
    Device Name
    MRT-35A V9.0
    Date Cleared
    1997-02-04

    (78 days)

    Product Code
    Regulation Number
    892.1000
    Reference & Predicate Devices
    Why did this record match?
    Reference Devices :

    K961842, K962138

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

    Imaging of the whole body (including the head, abdomen, heart, pelvis, spine, blood vessels, limbs and extremities), fluid visualization, 2D/3D Imaging, MR Angiography, MR Fluoroscopy.

    Device Description

    The MRT-35A v9.0 is a modification of the MRT-35A system which uses a 0.35T superconducting magnet. The MRT-35A v9.0 is an incremental upgrade to an MRT-35A system which is configured with version 8 hardware and software. The 9.0 upgrade replaces the version 8 computer system. The computer architecture, operational characteristics and user software follow the same design considerations cleared by Flexart™ and Visart™ systems. This 9.0 upgrade makes no change to the MRT-35A version 8 series magnet, gradient system or coil set.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the MRT-35A v9.0 device, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the MRT-35A v9.0 are implicitly defined by its equivalency to previously cleared devices (MRT-35A v8.0 and Flexart™) and its demonstrated adherence to "consensus standards requirements" for image quality. The performance is reported by comparing key safety and image performance parameters to these predicate devices.

    Acceptance Criteria CategorySpecific ParameterAcceptance Criterion (Implicitly based on Predicate Device Performance)Reported MRT-35A v9.0 Performance
    Safety ParametersMaximum static field strength0.35 T (MRT-35A v8.0) / 0.5 T (Flexart™)0.35 T
    Rate of change of magnetic field6.83 T/sec (MRT-35A v8.0) / 11 T/sec (Flexart™)6.83 T/sec
    Max. radio frequency power deposition0.34 W/kg (MRT-35A v8.0) /
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