{
  "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": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Ramat Gan",
      "advisory_committee_description": "Radiology",
      "address_1": "The Heart Center, Sheba Medical Center",
      "address_2": "Tel Hashomer",
      "statement_or_summary": "Summary",
      "product_code": "POK",
      "openfda": {
        "registration_number": [
          "3034527804",
          "3040335643",
          "3007301305",
          "3015478020",
          "3022983474",
          "3029937167",
          "3017210169",
          "3010119782",
          "3044622018",
          "3033588305",
          "3017604664",
          "3032008018",
          "3016585383",
          "3011205675",
          "3019216",
          "2518586"
        ],
        "fei_number": [
          "3034527804",
          "3040335643",
          "3007301305",
          "3015478020",
          "3022983474",
          "3029937167",
          "3017210169",
          "3010119782",
          "3044622018",
          "3033588305",
          "3017604664",
          "3014269683",
          "3032008018",
          "3016585383",
          "3019216",
          "2518586"
        ],
        "device_name": "Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.2060",
        "device_class": "2"
      },
      "zip_code": "52621",
      "applicant": "Aisap",
      "decision_date": "2024-08-01",
      "decision_code": "SESE",
      "country_code": "IL",
      "device_name": "AISAP Cardio V1.0",
      "advisory_committee": "RA",
      "contact": "Robert  Klempfner",
      "expedited_review_flag": "",
      "k_number": "K234141",
      "state": "",
      "date_received": "2023-12-29",
      "review_advisory_committee": "RA",
      "postal_code": "52621",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}