{
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    "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": "P030012",
      "supplement_number": "",
      "applicant": "Hologic, Inc.",
      "street_1": "35 Crosby Dr.",
      "street_2": "",
      "city": "Bedford",
      "state": "MA",
      "zip": "01730",
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      "generic_name": "Lung computed tomography system, computer-aided diagnosis",
      "trade_name": "IMAGECHECKER CT CAD SOFTWARE SYSTEM",
      "product_code": "NRR",
      "advisory_committee": "RA",
      "advisory_committee_description": "Radiology",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "2003-04-16",
      "decision_date": "2004-07-08",
      "docket_number": "04M-0323",
      "fed_reg_notice_date": "2004-07-22",
      "decision_code": "APCB",
      "ao_statement": "APPROVAL FOR THE IMAGECHECKER CT CAD SOFTWARE SYSTEM - MODEL LN-1000.  THIS SOFTWARE SYSTEM IS INDICATED TO ASSIST RADIOLOGISTS IN THE DETECTION OF SOLID PULMONARY NODULES DURING REVIEW OF MULTIDETECTOR CT (MDCT) SCANS OF THE CHEST.  IT IS INTENDED TO BE USED AS AN ADJUNCT, ALERTING THE RADIOLOGIST - AFTER HIS OR HER INITIAL READING OF THE SCAN - TO REGIONS OF INTEREST (ROIS) THAT MAY HAVE BEEN INITIALLY OVERLOOKED.",
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