{ "companyId": "52013", "slug": "brainlab-ag-52013", "name": "Brainlab AG", "clearances": { "total": 143, "last12Months": 3, "first": "1992-12-29", "latest": "2026-01-14" }, "medianReviewDays": 145, "productCodeCount": 15, "recalls": { "total": 47, "openLast12Months": 0, "recent": [ { "resNumber": "Z-1392-2025", "productCode": "LLZ", "status": "Open, Classified", "recallClass": "Class II", "initiated": "2025-02-10", "reason": "Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notification." }, { "resNumber": "Z-1292-2023", "productCode": "OLO", "status": "Open, Classified", "recallClass": "Class II", "initiated": "2023-03-02", "reason": "Risk of mechanical instability due to potential manufacturing error of the device" }, { "resNumber": "Z-1259-2023", "productCode": "IYE", "status": "Open, Classified", "recallClass": "Class II", "initiated": "2023-02-14", "reason": "Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template" }, { "resNumber": "Z-0733-2022", "productCode": "IYE", "status": "Open, Classified", "recallClass": "Class II", "initiated": "2022-02-25", "reason": "The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs." }, { "resNumber": "Z-1846-2021", "productCode": "IYE", "status": "Terminated", "recallClass": "Class II", "initiated": "2021-05-14", "reason": "Display of potential patient movement might be delayed to the user for high dose treatments." } ] }, "registration": { "sites": 2, "countries": [ "US" ] }, "productCodes": [ { "code": "HAW", "deviceName": "Neurological Stereotaxic Instrument", "clearances": 59, "latest": "2025-01-28", "medianReviewDays": 184 }, { "code": "IYE", "deviceName": "Accelerator, Linear, Medical", "clearances": 23, "latest": "2026-01-14", "medianReviewDays": 67 }, { "code": "OLO", "deviceName": "Orthopedic Stereotaxic Instrument", "clearances": 21, "latest": "2025-09-12", "medianReviewDays": 135 }, { "code": "LLZ", "deviceName": "System, Image Processing, Radiological", "clearances": 14, "latest": "2025-10-16", "medianReviewDays": 106 }, { "code": "MUJ", "deviceName": "System, Planning, Radiation Therapy Treatment", "clearances": 11, "latest": "2025-06-17", "medianReviewDays": 133 }, { "code": "LHN", "deviceName": "System, Radiation Therapy, Charged-Particle, Medical", "clearances": 3, "latest": "2008-06-24", "medianReviewDays": 160 }, { "code": "QIH", "deviceName": "Automated Radiological Image Processing Software", "clearances": 3, "latest": "2025-06-13", "medianReviewDays": 200 }, { "code": "JAI", "deviceName": "Couch, Radiation Therapy, Powered", "clearances": 2, "latest": "2012-06-29", "medianReviewDays": 129 }, { "code": "HBL", "deviceName": "Holder, Head, Neurosurgical (Skull Clamp)", "clearances": 1, "latest": "2013-04-26", "medianReviewDays": 275 }, { "code": "JAK", "deviceName": "System, X-Ray, Tomography, Computed", "clearances": 1, "latest": "2012-05-07", "medianReviewDays": 140 }, { "code": "KXK", "deviceName": "Source, Brachytherapy, Radionuclide", "clearances": 1, "latest": "1992-12-30", "medianReviewDays": 308 }, { "code": "OWB", "deviceName": "Interventional Fluoroscopic X-Ray System", "clearances": 1, "latest": "2025-07-22", "medianReviewDays": 259 }, { "code": "PGW", "deviceName": "Ear, Nose, And Throat Stereotaxic Instrument", "clearances": 1, "latest": "2023-04-27", "medianReviewDays": 135 }, { "code": "QQC", "deviceName": "Brain Stimulation Programming Planning Software.", "clearances": 1, "latest": "2022-04-19", "medianReviewDays": 124 }, { "code": "SBF", "deviceName": "Orthopedic Augmented Reality", "clearances": 1, "latest": "2025-05-16", "medianReviewDays": 261 } ], "productCodesShown": 15, "productCodesTotal": "15", "recentClearances": [ { "kNumber": "K254010", "deviceName": "ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface", "productCode": "IYE", "decisionDate": "2026-01-14", "reviewDays": 30 }, { "kNumber": "K252476", "deviceName": "Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout", "productCode": "LLZ", "decisionDate": "2025-10-16", "reviewDays": 70 }, { "kNumber": "K252562", "deviceName": "Spine & Trauma Navigation Instruments", "productCode": "OLO", "decisionDate": "2025-09-12", "reviewDays": 29 }, { "kNumber": "K243432", "deviceName": "Vascular Navigation PAD 2.0; Navigation Software Vascular PAD", "productCode": "OWB", "decisionDate": "2025-07-22", "reviewDays": 259 }, { "kNumber": "K243142", "deviceName": "Cranial 4Pi Immobilization", "productCode": "IYE", "decisionDate": "2025-06-23", "reviewDays": 266 }, { "kNumber": "K250440", "deviceName": "RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT", "productCode": "MUJ", "decisionDate": "2025-06-17", "reviewDays": 123 }, { "kNumber": "K243633", "deviceName": "Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)", "productCode": "QIH", "decisionDate": "2025-06-13", "reviewDays": 200 }, { "kNumber": "K243810", "deviceName": "TraumaCad Neo (1.1)", "productCode": "QIH", "decisionDate": "2025-06-04", "reviewDays": 175 }, { "kNumber": "K242569", "deviceName": "Mixed Reality Spine Navigation", "productCode": "SBF", "decisionDate": "2025-05-16", "reviewDays": 261 }, { "kNumber": "K243698", "deviceName": "Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT", "productCode": "HAW", "decisionDate": "2025-01-28", "reviewDays": 60 } ], "nameVariants": { "total": "9", "shown": [ { "name": "BRAINLAB SE", "dataset": "device/registrationlisting", "method": "normalised" }, { "name": "Brainlab", "dataset": "device/510k", "method": "normalised" }, { "name": "Brainlab , Ltd.", "dataset": "device/510k", "method": "normalised" }, { "name": "Brainlab AG", "dataset": "device/510k", "method": "normalised" }, { "name": "Brainlab AG", "dataset": "device/enforcement", "method": "normalised" }, { "name": "Brainlab AG", "dataset": "device/recall", "method": "normalised" }, { "name": "Brainlab Ltd.", "dataset": "device/registrationlisting", "method": "normalised" }, { "name": "Brainlab SE", "dataset": "device/510k", "method": "normalised" } ] }, "sources": { "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Brainlab%20AG%22", "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Brainlab%20AG%22" }, "provenance": [ { "dataset": "device/510k", "loadedAt": "2026-08-10T19:40:09Z", "ingestRun": 51 }, { "dataset": "device/classification", "loadedAt": "2026-08-10T06:54:18Z", "ingestRun": 2 }, { "dataset": "device/enforcement", "loadedAt": "2026-08-10T19:40:12Z", "ingestRun": 53 }, { "dataset": "device/event", "loadedAt": "2026-08-11T13:58:22Z", "ingestRun": 74 }, { "dataset": "device/recall", "loadedAt": "2026-08-10T19:40:11Z", "ingestRun": 52 }, { "dataset": "device/registrationlisting", "loadedAt": "2026-08-10T07:06:24Z", "ingestRun": 10 } ], "retrievedAt": "2026-08-11T14:48:53.034Z" }