{
  "code": "EHD",
  "deviceName": "Unit, X-Ray, Extraoral With Timer",
  "deviceClass": "II",
  "regulationNumber": "872.1800",
  "panel": "Dental",
  "definition": null,
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 190,
    "last12Months": 6
  },
  "adverseEvents": {
    "total": 8,
    "last12Months": 0
  },
  "reviewDays": {
    "median": 66,
    "sampleSize": 190
  },
  "recalls": {
    "total": 18,
    "recent": [
      {
        "resNumber": "Z-2117-2025",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "DIGIMED CO., LTD",
        "firmAsPublished": "DIGIMED CO., LTD",
        "reason": "Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.",
        "initiated": "2025-06-19"
      },
      {
        "resNumber": "Z-0517-2018",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Panoramic Rental Corp.",
        "firmAsPublished": "Panoramic Rental Corp.",
        "reason": "The lift motor used to raise and lower the overhead chassis will wear if not properly maintained according to the maintenance schedule.",
        "initiated": "2017-07-14"
      },
      {
        "resNumber": "Z-0016-2017",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Panoramic Rental Corp.",
        "firmAsPublished": "Panoramic Rental Corp.",
        "reason": "Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ray systems due to the potential for a safety nut to be ineffective, which could result in blunt force trauma that may impact the head, neck or shoulders.",
        "initiated": "2016-08-19"
      },
      {
        "resNumber": "Z-2716-2016",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Aribex Inc",
        "firmAsPublished": "Aribex Inc",
        "reason": "Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to \"overheat\", \"melt\", \"smoke\" and/or \"ignite.\"  Investigation found that the internal lithium ion batteries had entered into a thermal runaway condition as a result of a short circuit on the battery pack PCB.",
        "initiated": "2016-07-18"
      },
      {
        "resNumber": "Z-2717-2016",
        "status": "Terminated",
        "recallClass": "Class II",
        "firm": "Aribex Inc",
        "firmAsPublished": "Aribex Inc",
        "reason": "Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to \"overheat\", \"melt\", \"smoke\" and/or \"ignite.\"  Investigation found that the internal lithium ion batteries had entered into a thermal runaway condition as a result of a short circuit on the battery pack PCB.",
        "initiated": "2016-07-18"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K260367",
      "deviceName": "Portable Dental X-ray System Model PDX nova",
      "applicant": "PDX Co., Ltd.",
      "company": "PDX Co., Ltd.",
      "decisionDate": "2026-05-27",
      "dateReceived": "2026-02-04"
    },
    {
      "kNumber": "K253864",
      "deviceName": "NOMAD Pro 3",
      "applicant": "Dental Imaging Technologies Corporation",
      "company": "Dental Imaging Technologies Corporation",
      "decisionDate": "2026-03-20",
      "dateReceived": "2025-12-03"
    },
    {
      "kNumber": "K252110",
      "deviceName": "Dental X-RAY Unit (AJX200)",
      "applicant": "Guangzhou Ajax Medical Equipment Co., Ltd.",
      "company": "Guangzhou Ajax Medical Equipment Co., Ltd.",
      "decisionDate": "2026-03-12",
      "dateReceived": "2025-07-07"
    },
    {
      "kNumber": "K254018",
      "deviceName": "Portable Dental X-ray Device (GT-1)",
      "applicant": "Guilin Refine Medical Instrument Co., Ltd.",
      "company": "Guilin Refine Medical Instrument Co., Ltd.",
      "decisionDate": "2026-02-19",
      "dateReceived": "2025-12-15"
    },
    {
      "kNumber": "K252909",
      "deviceName": "Diagnostic X-Ray Equipment Model POCT22",
      "applicant": "Ningbo Runyes Medical Instrument Co., Ltd.",
      "company": "Ningbo Runyes Medical Instrument Co., Ltd.",
      "decisionDate": "2026-02-03",
      "dateReceived": "2025-09-12"
    },
    {
      "kNumber": "K251438",
      "deviceName": "Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )",
      "applicant": "Guilin Woodpecker Medical Instrument Co., Ltd.",
      "company": "Guilin Woodpecker Medical Instrument Co., Ltd.",
      "decisionDate": "2025-09-04",
      "dateReceived": "2025-05-09"
    },
    {
      "kNumber": "K242185",
      "deviceName": "Rextar Pro",
      "applicant": "Raypia Co., Ltd.",
      "company": "Raypia Co., Ltd.",
      "decisionDate": "2024-12-04",
      "dateReceived": "2024-07-25"
    },
    {
      "kNumber": "K242591",
      "deviceName": "XERO-alpha",
      "applicant": "DRTECH Corporation",
      "company": "DRTECH Corporation",
      "decisionDate": "2024-11-01",
      "dateReceived": "2024-08-30"
    },
    {
      "kNumber": "K241963",
      "deviceName": "WERAY",
      "applicant": "Picopack Co., Ltd.",
      "company": "Picopack Co., Ltd.",
      "decisionDate": "2024-07-30",
      "dateReceived": "2024-07-03"
    },
    {
      "kNumber": "K241305",
      "deviceName": "LifeRay Intraoral Handheld X-ray System",
      "applicant": "Lucas Lifecare",
      "company": "LUCAS LIFECARE, LLC",
      "decisionDate": "2024-07-05",
      "dateReceived": "2024-05-09"
    }
  ],
  "topApplicants": [
    {
      "name": "Planmeca Oy",
      "count": 13
    },
    {
      "name": "Villa Sistemi Medicali S.P.A.",
      "count": 7
    },
    {
      "name": "Trophy Radiologie",
      "count": 6
    },
    {
      "name": "VATECH Co., Ltd.",
      "count": 6
    },
    {
      "name": "Dentsply Intl.",
      "count": 4
    }
  ],
  "topCompanies": [
    {
      "name": "Planmeca Oy",
      "count": 13,
      "spellings": 1
    },
    {
      "name": "Villa Sistemi Medicali S.P.A.",
      "count": 7,
      "spellings": 1
    },
    {
      "name": "DIGIMED CO., LTD",
      "count": 6,
      "spellings": 2
    },
    {
      "name": "Trophy Radiologie",
      "count": 6,
      "spellings": 1
    },
    {
      "name": "VATECH Co., Ltd.",
      "count": 6,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "PDX Co., Ltd.",
      "since": "2026-05-27",
      "kNumber": "K260367"
    },
    {
      "name": "Dental Imaging Technologies Corporation",
      "since": "2026-03-20",
      "kNumber": "K253864"
    },
    {
      "name": "Guangzhou Ajax Medical Equipment Co., Ltd.",
      "since": "2026-03-12",
      "kNumber": "K252110"
    },
    {
      "name": "Guilin Refine Medical Instrument Co., Ltd.",
      "since": "2026-02-19",
      "kNumber": "K254018"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-08-01",
        "observed": 2,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-05-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-06-01",
        "observed": 4,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2024-10-01",
        "observed": 1,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      }
    ],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "EHD (Unit, X-Ray, Extraoral With Timer) has two findings, most consequential first. 4 first-time filers in the last 12 months, including PDX Co., Ltd. and Dental Imaging Technologies Corporation (K260367, K253864, K252110, K254018). The code is crowded, scoring 84 of 100 — 115 companies hold a clearance here and 6 arrived in the last 12 months (EHD:crowding).",
    "severity": 44,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "4 first-time filers in the last 12 months, including PDX Co., Ltd. and Dental Imaging Technologies Corporation",
        "recordIds": [
          "K260367",
          "K253864",
          "K252110",
          "K254018"
        ],
        "severity": 44
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 84 of 100 — 115 companies hold a clearance here and 6 arrived in the last 12 months",
        "recordIds": [
          "EHD:crowding"
        ],
        "severity": 20
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3AEHD"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEHD"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AEHD"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AEHD"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AEHD"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AEHD"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AEHD"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.691Z"
}