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510(k) Data Aggregation

    K Number
    K022667
    Device Name
    HCMI X-RAY
    Date Cleared
    2002-10-22

    (71 days)

    Product Code
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTH CARE MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    "HCMI X-Ray" High Frequency Radiographic System is intended for use by a qualified/trained doctor or technician or both to perform general purpose radiographic examinations of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in the prone or supine position.
    Device Description
    The "HCMI X-Ray" is a radiographic high frequency stationary x-ray unit which operates from 120/220 V 50-60~ AC. HCMI X-Ray Systems available: They are always sold with a radiographic table, either elevating or non-elevating. A wall stand with bucky is optional. The FST-10 tubestand is supplied.
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    K Number
    K022737
    Device Name
    HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC
    Date Cleared
    2002-10-22

    (64 days)

    Product Code
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTH CARE MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    "HCMI X-Ray" High Frequency Chiropractic Radiographic System is intended for use by a qualified/trained doctor or technician or both to perform general purpose radiographic examinations of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing or lying in the prone or supine position.
    Device Description
    The "HCMI X-Ray" is a chiropractic radiographic high frequency stationary x-ray unit which operates from 120/220 V 50-60~ AC. The standard system includes the high voltage generator, control panel, a Model S-82RM Tube Stand, and HC-172-F wall mount cassette holder. The tube stand employs a Toshiba tube head and a certified Eureka collimator. A radiographic table, one of several models, is optional. A wall stand with bucky is optional.
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