Brainlab AG
FDA 510(k) & PMA Approved Produkte — 50 products
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Produkte insgesamt50
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Neueste FDA-Entscheidung
| Typ | Nummer | Produktname | Code | Datum | Aktionen |
|---|---|---|---|---|---|
| 510(k) | K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | LLZ | 2025-10-16 | Anzeigen |
| 510(k) | K252562 | Spine & Trauma Navigation Instruments | OLO | 2025-09-12 | Anzeigen |
| 510(k) | K243432 | Vascular Navigation PAD 2.0; Navigation Software Vascular PAD | OWB | 2025-07-22 | Anzeigen |
| 510(k) | K243142 | Cranial 4Pi Immobilization | IYE | 2025-06-23 | Anzeigen |
| 510(k) | K250440 | 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 | MUJ | 2025-06-17 | Anzeigen |
| 510(k) | K243633 | 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) | QIH | 2025-06-13 | Anzeigen |
| 510(k) | K242569 | Mixed Reality Spine Navigation | SBF | 2025-05-16 | Anzeigen |
| 510(k) | K243698 | Kranialer Ausrichtungs-System, mit Kranialer Ausrichtungs-Software mit LITT; Cirq Ausrichtungs-Software Kranial Biopsie; Cirq Ausrichtungs-Software Kranial sEEG; VarioGuide Ausrichtungs-Software Kranial; Cirq Ausrichtungs-Software Kranial LITT | HAW | 2025-01-28 | Anzeigen |
| 510(k) | K240431 | ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface | IYE | 2024-07-24 | Anzeigen |
| 510(k) | K240701 | Drill Guide; Drill Bit; Spine & Trauma Navigation | OLO | 2024-05-23 | Anzeigen |
| 510(k) | K232759 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | LLZ | 2024-05-21 | Anzeigen |
| 510(k) | K234047 | Automatic Registration | OLO | 2024-03-20 | Anzeigen |
| 510(k) | K223864 | Kranialer Ausrichtungs-System, Kranialer Ausrichtungs-Software, Cirq Ausrichtungs-Software Kranial Biopsie, Cirq Ausrichtungs-Software Kranial sEEG, Varioguide Ausrichtungs-Software Kranial | HAW | 2023-09-09 | Anzeigen |
| 510(k) | K223553 | Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine | OLO | 2023-08-02 | Anzeigen |
| 510(k) | K223288 | Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI | HAW | 2023-07-21 | Anzeigen |
| 510(k) | K223106 | Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) | QIH | 2023-07-14 | Anzeigen |
| 510(k) | K231052 | ExacTrac Dynamic 1.1.2 | IYE | 2023-05-11 | Anzeigen |
| 510(k) | K223734 | ENT EM | PGW | 2023-04-27 | Anzeigen |
| 510(k) | K223552 | Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial | HAW | 2023-04-19 | Anzeigen |
| 510(k) | K223279 | RT Elements (4.0) | MUJ | 2023-03-14 | Anzeigen |
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