{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-19",
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      "pma_number": "P150043",
      "supplement_number": "",
      "applicant": "Qview Medical, Inc.",
      "street_1": "4546 El Camino Real, Suite 215",
      "street_2": "",
      "city": "Los Altos",
      "state": "CA",
      "zip": "94022",
      "zip_ext": "",
      "generic_name": "Analyzer, medical image",
      "trade_name": "QVCAD SYSTEM",
      "product_code": "MYN",
      "advisory_committee": "RA",
      "advisory_committee_description": "Radiology",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "2015-11-23",
      "decision_date": "2016-11-09",
      "docket_number": "16M-3914",
      "fed_reg_notice_date": "2016-11-16",
      "decision_code": "APRL",
      "ao_statement": "Approval for the QVCAD System.  The QVCAD System is indicated for use as an aid to the reader during screening procedures in searching images of female breasts produced by the somo.v Automated Breast Ultrasound System (screening mammography BI- RADS® Assessment Category 1 or 2, and BI-RADS Composition/Density c or d) to detect mammography-occult lesions in regions not known to have suspicious findings. The indicators produced by the QVCAD System are not  intended  to  be  used  for  diagnostic  characterization  of  suspicious findings.",
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        "device_name": "Analyzer, Medical Image",
        "medical_specialty_description": "Radiology",
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