{
  "code": "QAS",
  "deviceName": "Radiological Computer-Assisted Triage And Notification Software",
  "deviceClass": "II",
  "regulationNumber": "892.2080",
  "panel": "Radiology",
  "definition": "Computer-assisted triage and notification software intended to aid in prioritisation of medical images.",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 86,
    "last12Months": 16
  },
  "adverseEvents": {
    "total": 0,
    "last12Months": 0
  },
  "reviewDays": {
    "median": 103,
    "sampleSize": 86
  },
  "recalls": {
    "total": 0,
    "recent": []
  },
  "recentClearances": [
    {
      "kNumber": "K261085",
      "deviceName": "Rapid Vessel Occlusion (Rapid VO)",
      "applicant": "iSchemaview",
      "company": "Ischemaview Incorporated",
      "decisionDate": "2026-07-13",
      "dateReceived": "2026-04-01"
    },
    {
      "kNumber": "K260729",
      "deviceName": "Vascular Assist Occlusion Triage (VAOT) (v1.0)",
      "applicant": "GuideAI Health",
      "company": "GuideAI Health",
      "decisionDate": "2026-06-18",
      "dateReceived": "2026-03-06"
    },
    {
      "kNumber": "K261317",
      "deviceName": "BriefCase-Triage",
      "applicant": "Aidoc Medical , Ltd.",
      "company": "Aidoc Medical , Ltd.",
      "decisionDate": "2026-05-14",
      "dateReceived": "2026-04-21"
    },
    {
      "kNumber": "K253163",
      "deviceName": "EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)",
      "applicant": "Ever Fortune.Ai, Co., Ltd.",
      "company": "Ever Fortune.Ai, Co., Ltd.",
      "decisionDate": "2026-04-22",
      "dateReceived": "2025-09-26"
    },
    {
      "kNumber": "K252421",
      "deviceName": "JLK-NCCT",
      "applicant": "JLK, Inc.",
      "company": "JLK, Inc.",
      "decisionDate": "2026-03-24",
      "dateReceived": "2025-08-01"
    },
    {
      "kNumber": "K253818",
      "deviceName": "Annalise Enterprise",
      "applicant": "Harrison-AI Medical Pty, Ltd.",
      "company": "Harrison-AI Medical Pty, Ltd.",
      "decisionDate": "2026-03-03",
      "dateReceived": "2025-11-28"
    },
    {
      "kNumber": "K253578",
      "deviceName": "BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device",
      "applicant": "Aidoc Medical , Ltd.",
      "company": "Aidoc Medical , Ltd.",
      "decisionDate": "2026-02-26",
      "dateReceived": "2025-11-17"
    },
    {
      "kNumber": "K251195",
      "deviceName": "BriefCase-Triage",
      "applicant": "Aidoc Medical , Ltd.",
      "company": "Aidoc Medical , Ltd.",
      "decisionDate": "2026-01-27",
      "dateReceived": "2025-04-17"
    },
    {
      "kNumber": "K252970",
      "deviceName": "BriefCase-Triage: CARE Multi-triage CT Body",
      "applicant": "Aidoc Medical , Ltd.",
      "company": "Aidoc Medical , Ltd.",
      "decisionDate": "2026-01-07",
      "dateReceived": "2025-09-17"
    },
    {
      "kNumber": "K250694",
      "deviceName": "Scaida BrainCT-ICH (v1.0)",
      "applicant": "Mlhealth 360",
      "company": "Mlhealth 360",
      "decisionDate": "2025-11-25",
      "dateReceived": "2025-03-07"
    }
  ],
  "topApplicants": [
    {
      "name": "Aidoc Medical , Ltd.",
      "count": 25
    },
    {
      "name": "Ischemaview, Inc.",
      "count": 7
    },
    {
      "name": "Avicenna.Ai",
      "count": 5
    },
    {
      "name": "Ever Fortune.Ai, Co., Ltd.",
      "count": 5
    },
    {
      "name": "Annalise-Ai Pty , Ltd.",
      "count": 4
    }
  ],
  "topCompanies": [
    {
      "name": "Aidoc Medical , Ltd.",
      "count": 25,
      "spellings": 1
    },
    {
      "name": "Ischemaview Incorporated",
      "count": 10,
      "spellings": 4
    },
    {
      "name": "Avicenna.Ai",
      "count": 5,
      "spellings": 1
    },
    {
      "name": "Ever Fortune.Ai, Co., Ltd.",
      "count": 5,
      "spellings": 1
    },
    {
      "name": "Annalise-Ai Pty , Ltd.",
      "count": 4,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "GuideAI Health",
      "since": "2026-06-18",
      "kNumber": "K260729"
    },
    {
      "name": "Harrison-AI Medical Pty, Ltd.",
      "since": "2026-03-03",
      "kNumber": "K253818"
    },
    {
      "name": "Mlhealth 360",
      "since": "2025-11-25",
      "kNumber": "K250694"
    },
    {
      "name": "A2z Radiology Ai, Inc.",
      "since": "2025-11-24",
      "kNumber": "K252366"
    }
  ],
  "baseline": {
    "months": [],
    "sufficientMonths": 0,
    "method": null
  },
  "signal": {
    "summary": "QAS (Radiological Computer-Assisted Triage And Notification Software) has two findings, most consequential first. 4 first-time filers in the last 12 months, including GuideAI Health and Harrison-AI Medical Pty, Ltd (K260729, K253818, K250694, K252366). The code is crowded, scoring 75 of 100 — 28 companies hold a clearance here and 16 arrived in the last 12 months (QAS:crowding).",
    "severity": 44,
    "factors": [
      {
        "kind": "new_entrant",
        "detail": "4 first-time filers in the last 12 months, including GuideAI Health and Harrison-AI Medical Pty, Ltd.",
        "recordIds": [
          "K260729",
          "K253818",
          "K250694",
          "K252366"
        ],
        "severity": 44
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 75 of 100 — 28 companies hold a clearance here and 16 arrived in the last 12 months",
        "recordIds": [
          "QAS: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%3AQAS"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AQAS"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3AQAS"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3AQAS"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AQAS"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AQAS"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AQAS"
    }
  ],
  "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": "2026-08-11T13:51:45.753Z"
}