{
  "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": "2026-09-21",
    "results": {
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  "results": [
    {
      "pma_number": "P980025",
      "supplement_number": "S002",
      "applicant": "Carestream Dental, LLC",
      "street_1": "1765 The Exchange",
      "street_2": "",
      "city": "Atlanta",
      "state": "GA",
      "zip": "30339",
      "zip_ext": "",
      "generic_name": "Analyzer, medical image",
      "trade_name": "LOGICON CARIES DETECTOR",
      "product_code": "MYN",
      "advisory_committee": "RA",
      "advisory_committee_description": "Radiology",
      "supplement_type": "Normal 180 Day Track",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "expedited_review_flag": "N",
      "date_received": "2013-02-19",
      "decision_date": "2014-07-22",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR THE ADDITION OF SOFTWARE MODULE PRESCAN TO LOGICON CARIES DETECTOR.  THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LOGICON CARIES DETECTOR AND HAS REVISED INDICATIONS FOR USE: THE LOGICON CARIES DETECTOR IS A SOFTWARE DEVICE THAT IS AN AID IN THE DIAGNOSIS OF CARIES THAT HAVE PENETRATED INTO THE DENTIN, ON UN-RESTORED PROXIMAL SURFACES OF SECONDARY DENTITION THROUGH THE STATISTICAL ANALYSIS OF DIGITAL INTRA-ORAL RADIOGRAPHIC IMAGERY. THE DEVICE PROVIDES ADDITIONAL INFORMATION FOR THE CLINICIAN TO USE IN HIS/HER DIAGNOSIS OF A TOOTH SURFACE SUSPECTED OF BEING CARIOUS. IT IS DESIGNED TO WORK IN CONJUNCTION WITH AN EXISTING CARESTREAM DENTAL RVG DIGITAL X-RAY RADIOGRAPHIC SYSTEM WITH DENTAL IMAGING SOFTWARE (DIS) FOR WINDOWS XP OR HIGHER.",
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        "device_name": "Analyzer, Medical Image",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.2070",
        "device_class": "2"
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}