{
  "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": "2026-10-12",
    "results": {
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      "pma_number": "P970058",
      "supplement_number": "",
      "applicant": "Hologic, Inc.",
      "street_1": "35 Crosby Dr.",
      "street_2": "",
      "city": "Bedford",
      "state": "MA",
      "zip": "01730",
      "zip_ext": "",
      "generic_name": "Analyzer, medical image",
      "trade_name": "M1000 IMAGECHECKER",
      "product_code": "MYN",
      "advisory_committee": "RA",
      "advisory_committee_description": "Radiology",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "N",
      "date_received": "1997-12-16",
      "decision_date": "1998-06-26",
      "docket_number": "98M-0618",
      "fed_reg_notice_date": "1998-08-12",
      "decision_code": "APRL",
      "ao_statement": "The Image Checker M1000 is a computer system intended to identify and mark regions of interest on routine screening mammograms to bring them tot he attention of the radiologist after the initial readin ghas been completed.  Thus, the system assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review.",
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}