{
  "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",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 11
    }
  },
  "results": [
    {
      "pma_number": "P080003",
      "supplement_number": "S001",
      "applicant": "Hologic, Inc.",
      "street_1": "35 Crosby Dr.",
      "street_2": "",
      "city": "Bedford",
      "state": "MA",
      "zip": "01730",
      "zip_ext": "",
      "generic_name": "Digital breast tomosynthesis",
      "trade_name": "SELENIA DIMENSIONS 3D SYSTEM",
      "product_code": "OTE",
      "advisory_committee": "RA",
      "advisory_committee_description": "Radiology",
      "supplement_type": "Panel Track",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2012-10-09",
      "decision_date": "2013-05-16",
      "docket_number": "13M-0595",
      "fed_reg_notice_date": "2013-05-23",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL  FOR THE SELENIA DIMENSIONS 3D SYSTEM.  THIS DEVICE IS INDICATED TO GENERATE DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER. THE SELENIA DIMENSIONS (2D OR 3D) SYSTEM IS INTENDED FOR USE IN THE SAME CLINICAL APPLICATIONS AS A 2D MAMMOGRAPHY SYSTEM FOR SCREENING MAMMOGRAMS. SPECIFICALLY, THE SELENIA DIMENSIONS SYSTEM CAN BE USED TO GENERATE 2D DIGITAL MAMMOGRAMS AND 3D MAMMOGRAMS. EACH SCREENING EXAMINATION MAY CONSIST OF: A 2D FFDM IMAGE SET; OR A 2D AND 3D IMAGE SET, WHERE THE 2D IMAGE CAN BE EITHER A FFDM OR A 2D IMAGE GENERATED FROM THE 3D IMAGE SET. THE SELENIA DIMENSIONS SYSTEM MAY ALSO BE USED FOR ADDITIONAL DIAGNOSTIC WORKUP OF THE BREAST.",
      "openfda": {
        "registration_number": [
          "3012127758",
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        "fei_number": [
          "3012127758",
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          "3029521953",
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          "3001722928",
          "3004977335",
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        ],
        "device_name": "Digital Breast Tomosynthesis",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}