{
  "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": "2026-05-25",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Ann Arbor",
      "advisory_committee_description": "Radiology",
      "address_1": "6190 Jackson Rd.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "NQQ",
      "openfda": {
        "device_name": "System, Imaging, Optical Coherence Tomography (Oct)",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.1560",
        "device_class": "2",
        "registration_number": [
          "2024311",
          "3009882464",
          "1220477",
          "3004837686",
          "3004091615",
          "2246552",
          "3042970803",
          "3017654247",
          "3012198618",
          "3013276158",
          "3007603861",
          "3009600098",
          "3005228872",
          "2030624",
          "3010126772",
          "3012179728",
          "3013440400",
          "3011578544",
          "2024168",
          "3027259266",
          "3013351723",
          "2245304",
          "3042929028",
          "3038165043",
          "1221051",
          "3043527620",
          "3021630097"
        ],
        "fei_number": [
          "2024311",
          "3009882464",
          "1220477",
          "3004837686",
          "3004091615",
          "2246552",
          "3042970803",
          "3000206435",
          "3012198618",
          "3013276158",
          "3017654247",
          "3007603861",
          "3009600098",
          "3005228872",
          "3010126772",
          "3012179728",
          "3013440400",
          "3011578544",
          "2024168",
          "3027259266",
          "3013351723",
          "2245304",
          "3042929028",
          "3038165043",
          "1221051",
          "3043527620",
          "3021630097"
        ]
      },
      "zip_code": "48103",
      "applicant": "Terumo Cardiovascular Systems Thi Plant",
      "decision_date": "2025-07-02",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "OPUSWAVE Dual Sensor Imaging System",
      "advisory_committee": "RA",
      "contact": "Rahul Reddy  Chinkeri",
      "expedited_review_flag": "",
      "k_number": "K250684",
      "state": "MI",
      "date_received": "2025-03-06",
      "review_advisory_committee": "CV",
      "postal_code": "48103",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}