{ "code": "QIH", "deviceName": "Automated Radiological Image Processing Software", "deviceClass": "II", "regulationNumber": "892.2050", "panel": "Radiology", "definition": "To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data.", "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 314, "last12Months": 93 }, "adverseEvents": { "total": 70, "last12Months": 64 }, "reviewDays": { "median": 140, "sampleSize": 314 }, "recalls": { "total": 2, "recent": [ { "resNumber": "Z-2767-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "PIE Medical Imaging B.V.", "firmAsPublished": "PIE Medical Imaging B.V.", "reason": "User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the following occur: affected software is used, and the user has access only to 3D Echo OR Mitral 3D Echo, and the dataset being analyzed is a Philips 3D echo dataset containing Color Doppler information", "initiated": "2026-05-07" }, { "resNumber": "Z-2111-2021", "status": "Terminated", "recallClass": "Class II", "firm": "Caption Health", "firmAsPublished": "Caption Health", "reason": "The firm is aware of a issue with ultrasound software that results in unintended video frames being included. This could lead to an incorrect automated ejection fraction (AutoEF) and image quality score (IQS) estimates.", "initiated": "2021-05-19" } ] }, "recentClearances": [ { "kNumber": "K261349", "deviceName": "SwiftMR", "applicant": "Airs Medical, Inc.", "company": "Airs Medical, Inc.", "decisionDate": "2026-07-24", "dateReceived": "2026-04-24" }, { "kNumber": "K260192", "deviceName": "DIANA", "applicant": "ROPCA ApS", "company": "ROPCA ApS", "decisionDate": "2026-07-24", "dateReceived": "2026-01-22" }, { "kNumber": "K254096", "deviceName": "VELMENI for DENTISTS (V4D) 3D", "applicant": "Velmeni, Inc.", "company": "Velmeni, Inc.", "decisionDate": "2026-07-23", "dateReceived": "2025-12-19" }, { "kNumber": "K261535", "deviceName": "Hi-D Imaging 4TAVR", "applicant": "Hi-D Imaging AG", "company": "Hi-D Imaging AG", "decisionDate": "2026-07-20", "dateReceived": "2026-05-08" }, { "kNumber": "K260206", "deviceName": "SkeletonPlanner", "applicant": "UPlanner B.V. - Presurgeo", "company": "UPlanner B.V. - Presurgeo", "decisionDate": "2026-07-15", "dateReceived": "2026-01-23" }, { "kNumber": "K260973", "deviceName": "InferOperate Suite", "applicant": "Beijing Infervision Healthcare Medical Technology Co., Ltd.", "company": "Beijing Infervision Healthcare Medical Technology Co., Ltd.", "decisionDate": "2026-07-07", "dateReceived": "2026-03-24" }, { "kNumber": "K253969", "deviceName": "ADAS 3D", "applicant": "Adas3D Medical S.L.", "company": "Adas3D Medical S.L.", "decisionDate": "2026-06-29", "dateReceived": "2025-12-11" }, { "kNumber": "K253628", "deviceName": "Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)", "applicant": "Agada Medical, Ltd.", "company": "Agada Medical, Ltd.", "decisionDate": "2026-06-29", "dateReceived": "2025-11-19" }, { "kNumber": "K253786", "deviceName": "syngo.CT Coronary Cockpit", "applicant": "Siemens Medical Solutions USA, Inc.", "company": "Siemens Medical Solutions USA, Inc.", "decisionDate": "2026-06-25", "dateReceived": "2025-11-26" }, { "kNumber": "K260316", "deviceName": "CMN Capillary Function with Oncology Virtual Expert", "applicant": "Cercare Medical A/S", "company": "Cercare Medical A/S", "decisionDate": "2026-06-22", "dateReceived": "2026-01-30" } ], "topApplicants": [ { "name": "Siemens Medical Solutions USA, Inc.", "count": 12 }, { "name": "Dia Imaging Analysis, Ltd.", "count": 10 }, { "name": "Shanghai United Imaging Healthcare Co., Ltd.", "count": 6 }, { "name": "Clarius Mobile Health Corp.", "count": 5 }, { "name": "Ischemaview, Inc.", "count": 5 } ], "topCompanies": [ { "name": "Siemens Medical Solutions USA, Inc.", "count": 12, "spellings": 1 }, { "name": "Dia Imaging Analysis, Ltd.", "count": 10, "spellings": 1 }, { "name": "Shanghai United Imaging Healthcare Co., Ltd.", "count": 6, "spellings": 1 }, { "name": "Clarius Mobile Health Corp.", "count": 5, "spellings": 1 }, { "name": "Ischemaview Incorporated", "count": 5, "spellings": 1 } ], "newEntrants": [ { "name": "ROPCA ApS", "since": "2026-07-24", "kNumber": "K260192" }, { "name": "Velmeni, Inc.", "since": "2026-07-23", "kNumber": "K254096" }, { "name": "UPlanner B.V. - Presurgeo", "since": "2026-07-15", "kNumber": "K260206" }, { "name": "Agada Medical, Ltd.", "since": "2026-06-29", "kNumber": "K253628" }, { "name": "Cercare Medical A/S", "since": "2026-06-22", "kNumber": "K260316" }, { "name": "Anumana, Inc.", "since": "2026-06-15", "kNumber": "K260300" }, { "name": "Brainomix Limited", "since": "2026-06-12", "kNumber": "K260406" }, { "name": "Keya Medical Technology Co., Ltd.", "since": "2026-06-04", "kNumber": "K260497" } ], "baseline": { "months": [ { "month": "2024-07-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-12-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-05-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-06-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-08-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-09-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-10-01", "observed": 5, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-11-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-12-01", "observed": 6, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-01-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-02-01", "observed": 6, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2026-03-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false } ], "sufficientMonths": 0, "method": null }, "signal": { "summary": "QIH (Automated Radiological Image Processing Software) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-2767-2026). 40 first-time filers in the last 12 months, including ROPCA ApS and Velmeni, Inc (K260192, K254096, K260206, K253628, K260316). The code is crowded, scoring 98 of 100 — 175 companies hold a clearance here and 93 arrived in the last 12 months (QIH:crowding).", "severity": 75, "factors": [ { "kind": "recall", "detail": "1 recall opened in the last 12 months and not yet terminated (Class II)", "recordIds": [ "Z-2767-2026" ], "severity": 75 }, { "kind": "new_entrant", "detail": "40 first-time filers in the last 12 months, including ROPCA ApS and Velmeni, Inc.", "recordIds": [ "K260192", "K254096", "K260206", "K253628", "K260316" ], "severity": 50 }, { "kind": "crowding", "detail": "the code is crowded, scoring 98 of 100 — 175 companies hold a clearance here and 93 arrived in the last 12 months", "recordIds": [ "QIH: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%3AQIH" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AQIH" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AQIH" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AQIH" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AQIH" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AQIH" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AQIH" } ], "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": "2026-08-11T13:51:45.754Z" }