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510(k) Data Aggregation

    K Number
    K041185
    Device Name
    TORSO ARRAY COIL, MODEL 558GE-64
    Manufacturer
    IGC-MEDICAL ADVANCES, INC.
    Date Cleared
    2004-05-14

    (8 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    IGC-MEDICAL ADVANCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the Musculoskeletal structures, soft tissue and vascular structures of the torso, pelvis, and abdomen.
    Device Description
    Model 558GE-64 Torso Array Coil. Compatible with GE Signa EXCITE 1.5T MR Systems.
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    K Number
    K040640
    Device Name
    MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL
    Manufacturer
    IGC-MEDICAL ADVANCES, INC.
    Date Cleared
    2004-03-22

    (12 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    IGC-MEDICAL ADVANCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Magnetic resonance imaging (MRI) of the musculoskeletal structures, soft tissue and vascular structures of the lower extremities.
    Device Description
    Model 475 8 Channel T/R Phased Array Lower Extremity Coil. Compatible with GE and Siemens 1.5T and 3.0T MR Systems.
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    K Number
    K033292
    Device Name
    AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12
    Manufacturer
    IGC-MEDICAL ADVANCES, INC.
    Date Cleared
    2003-11-26

    (43 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    IGC-MEDICAL ADVANCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures within the anatomic regions from the chest to the pelvic region.
    Device Description
    Model 554HI-12 RAPID Body Coil. Compatible with Hitachi AIRIS-Elite MR Systems.
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    K Number
    K023848
    Device Name
    MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:
    Manufacturer
    IGC-MEDICAL ADVANCES, INC.
    Date Cleared
    2003-02-14

    (87 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    IGC-MEDICAL ADVANCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of adults and pediatrics of musculo-skeletal structures, soft tissue and vascular structures (mid-abdomen to mid-foot).
    Device Description
    Model 675GE-64 Peripheral Vascular Coil consisting of Model 665GE-64 Lower Extremity Flexible Array and Model 538GE-64 Medium General Purpose Flex Coil. Compatible with GE Signa 1.5T MRI systems with Phased Array option.
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    K Number
    K003366
    Device Name
    MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL
    Manufacturer
    IGC-MEDICAL ADVANCES, INC.
    Date Cleared
    2000-12-22

    (53 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    IGC-MEDICAL ADVANCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001312
    Device Name
    MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL
    Manufacturer
    IGC-MEDICAL ADVANCES, INC.
    Date Cleared
    2000-06-20

    (55 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    IGC-MEDICAL ADVANCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000589
    Device Name
    MODEL 445SI-64E QUADRATURE WRIST COIL
    Manufacturer
    IGC-MEDICAL ADVANCES, INC.
    Date Cleared
    2000-03-14

    (21 days)

    Product Code
    MOS
    Regulation Number
    892.1000
    Why did this record match?
    Applicant Name (Manufacturer) :

    IGC-MEDICAL ADVANCES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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