{ "code": "MUJ", "deviceName": "System, Planning, Radiation Therapy Treatment", "deviceClass": "II", "regulationNumber": "892.5050", "panel": "Radiology", "definition": null, "submissionTypeId": "1", "submissionType": "510(k)", "clearances": { "total": 257, "last12Months": 13 }, "adverseEvents": { "total": 102, "last12Months": 12 }, "reviewDays": { "median": 88, "sampleSize": 257 }, "recalls": { "total": 267, "recent": [ { "resNumber": "Z-2646-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "RAYSEARCH LABORATORIES AB", "firmAsPublished": "RAYSEARCH LABORATORIES AB", "reason": "Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.", "initiated": "2026-05-20" }, { "resNumber": "Z-2647-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "RAYSEARCH LABORATORIES AB", "firmAsPublished": "RAYSEARCH LABORATORIES AB", "reason": "Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.", "initiated": "2026-05-20" }, { "resNumber": "Z-1339-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Elekta Limited", "firmAsPublished": "Elekta, Inc.", "reason": "Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.", "initiated": "2025-12-12" }, { "resNumber": "Z-1340-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "Elekta Limited", "firmAsPublished": "Elekta, Inc.", "reason": "Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.", "initiated": "2025-12-12" }, { "resNumber": "Z-1102-2026", "status": "Open, Classified", "recallClass": "Class II", "firm": "RAYSEARCH LABORATORIES AB", "firmAsPublished": "RAYSEARCH LABORATORIES AB", "reason": "Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.", "initiated": "2025-11-28" } ] }, "recentClearances": [ { "kNumber": "K260750", "deviceName": "Virtual Cone (1.0)", "applicant": "Varian Medical Systems, Inc.", "company": "Varian Medical Systems, Inc.", "decisionDate": "2026-07-08", "dateReceived": "2026-03-06" }, { "kNumber": "K253050", "deviceName": "RadOncAI", "applicant": "Informai", "company": "Informai", "decisionDate": "2026-06-18", "dateReceived": "2025-09-22" }, { "kNumber": "K260207", "deviceName": "Multimodality Simulation Workspace (MM Sim) (v1.0.0)", "applicant": "Philips Medical Systems Nederland B.V.", "company": "Philips Medical Systems Nederland B.V.", "decisionDate": "2026-05-27", "dateReceived": "2026-01-23" }, { "kNumber": "K252784", "deviceName": "eXaSkin Plus", "applicant": "Anatomical Geometry S.L.", "company": "Anatomical Geometry S.L.", "decisionDate": "2026-05-22", "dateReceived": "2025-09-02" }, { "kNumber": "K253078", "deviceName": "ART.1-US", "applicant": "Seetreat Pty, Ltd.", "company": "Seetreat Pty, Ltd.", "decisionDate": "2026-05-14", "dateReceived": "2025-09-23" }, { "kNumber": "K252304", "deviceName": "syngo.via RT Image Suite VC10", "applicant": "Varian Medical Systems, Inc.", "company": "Varian Medical Systems, Inc.", "decisionDate": "2026-03-18", "dateReceived": "2025-07-24" }, { "kNumber": "K260308", "deviceName": "TrueFit Bolus", "applicant": "Adaptiiv Medical Technologies, Inc.", "company": "Adaptiiv Medical Technologies, Inc.", "decisionDate": "2026-02-19", "dateReceived": "2026-01-30" }, { "kNumber": "K252002", "deviceName": "Monaco RTP System (6.3)", "applicant": "Elekta Solutions AB", "company": "ELEKTA SOLUTIONS AB", "decisionDate": "2026-02-19", "dateReceived": "2025-06-27" }, { "kNumber": "K253091", "deviceName": "ART-Plan+ (v3.1.0)", "applicant": "Therapanacea Sas", "company": "Therapanacea Sas", "decisionDate": "2025-12-23", "dateReceived": "2025-09-23" }, { "kNumber": "K252109", "deviceName": "RayStation (2024A SP3)", "applicant": "RaySearch Laboratories AB (PUBL)", "company": "RaySearch Laboratories AB (publ)", "decisionDate": "2025-12-22", "dateReceived": "2025-07-07" } ], "topApplicants": [ { "name": "Varian Medical Systems, Inc.", "count": 27 }, { "name": "RaySearch Laboratories AB (PUBL)", "count": 15 }, { "name": "Siemens Medical Solutions USA, Inc.", "count": 13 }, { "name": "Brainlab AG", "count": 11 }, { "name": "Computerized Medical Systems, Inc.", "count": 9 } ], "topCompanies": [ { "name": "Varian Medical Systems, Inc.", "count": 33, "spellings": 2 }, { "name": "RaySearch Laboratories AB (publ)", "count": 15, "spellings": 1 }, { "name": "Siemens Medical Solutions USA, Inc.", "count": 13, "spellings": 1 }, { "name": "Nucletron BV", "count": 12, "spellings": 3 }, { "name": "Brainlab AG", "count": 11, "spellings": 1 } ], "newEntrants": [ { "name": "Informai", "since": "2026-06-18", "kNumber": "K253050" }, { "name": "Philips Medical Systems Nederland B.V.", "since": "2026-05-27", "kNumber": "K260207" }, { "name": "Anatomical Geometry S.L.", "since": "2026-05-22", "kNumber": "K252784" }, { "name": "Seetreat Pty, Ltd.", "since": "2026-05-14", "kNumber": "K253078" }, { "name": "Cosylab Jsc, Control System Laboratory", "since": "2025-11-20", "kNumber": "K250963" }, { "name": "Mvision AI OY", "since": "2025-09-04", "kNumber": "K250064" } ], "baseline": { "months": [ { "month": "2023-01-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-02-01", "observed": 13, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-03-01", "observed": 46, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-04-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-07-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-08-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2023-09-01", "observed": 4, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-02-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-03-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-05-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2024-10-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-01-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-02-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-04-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-05-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-06-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-08-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-09-01", "observed": 2, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-10-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-11-01", "observed": 3, "expectedLow": null, "expectedHigh": null, "isSufficient": false }, { "month": "2025-12-01", "observed": 1, "expectedLow": null, "expectedHigh": null, "isSufficient": false } ], "sufficientMonths": 0, "method": null }, "signal": { "summary": "MUJ (System, Planning, Radiation Therapy Treatment) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2646-2026, Z-2647-2026, Z-1339-2026, Z-1340-2026, Z-1102-2026). 6 first-time filers in the last 12 months, including Informai and Philips Medical Systems Nederland B.V (K253050, K260207, K252784, K253078, K250963). Clearances are running 165% slower — a median 233 days over the last 12 months against 88 days all-time (elapsed calendar days, not FDA review days) (MUJ:review_time:12m). The code is crowded, scoring 90 of 100 — 86 companies hold a clearance here and 13 arrived in the last 12 months (MUJ:crowding).", "severity": 75, "factors": [ { "kind": "recall", "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)", "recordIds": [ "Z-2646-2026", "Z-2647-2026", "Z-1339-2026", "Z-1340-2026", "Z-1102-2026" ], "severity": 75 }, { "kind": "new_entrant", "detail": "6 first-time filers in the last 12 months, including Informai and Philips Medical Systems Nederland B.V.", "recordIds": [ "K253050", "K260207", "K252784", "K253078", "K250963" ], "severity": 46 }, { "kind": "review_time_shift", "detail": "clearances are running 165% slower — a median 233 days over the last 12 months against 88 days all-time (elapsed calendar days, not FDA review days)", "recordIds": [ "MUJ:review_time:12m" ], "severity": 30 }, { "kind": "crowding", "detail": "the code is crowded, scoring 90 of 100 — 86 companies hold a clearance here and 13 arrived in the last 12 months", "recordIds": [ "MUJ: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%3AMUJ" }, { "label": "510k total", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMUJ" }, { "label": "510k recent decisions", "url": "https://api.fda.gov/device/510k.json?search=product_code%3AMUJ" }, { "label": "recalls", "url": "https://api.fda.gov/device/recall.json?search=product_code%3AMUJ" }, { "label": "enforcement", "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3AMUJ" }, { "label": "adverse events total", "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3AMUJ" }, { "label": "registrations", "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3AMUJ" } ], "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": "2026-08-11T13:51:45.747Z" }