Chrysalis Intelligence · Sponsors · Brainlab AG

Brainlab AG

Munich, DE · 43 510(k) clearances · 10 recalls

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Total clearances
43
2020-01-23 → 2025-10-16
Last 12 months
2
Product codes
10
Most recent
2025-10-16
Name variants in FDA filings: Brainlab AG / Brainlab , Ltd.
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
OLO Orthopedic Stereotaxic Instrument Class II Neurology 11 2025-09-12
HAW — — — 9 2025-01-28
IYE — — — 8 2025-06-23
LLZ System, Image Processing, Radiological Class II Radiology 5 2025-10-16
MUJ System, Planning, Radiation Therapy Treatment Class II Radiology 3 2025-06-17
QIH Automated Radiological Image Processing Software Class II Radiology 3 2025-06-13
OWB — — — 1 2025-07-22
SBF Orthopedic Augmented Reality Class II Neurology 1 2025-05-16
PGW — — — 1 2023-04-27
QQC Brain Stimulation Programming Planning Software. Class II Neurology 1 2022-04-19
Safety

Recalls (10)

Class I (serious)
0
Risk of injury / death
Total recalls
10
Currently ongoing
4
Most recent
2025-02-10
DateSeverityStatusRecall # ProductCodeReason
2025-02-10 Class II Ongoing Z-1392-2025 Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 — Under certain circumstances, it can occur that patient records from unrelated individuals are automatically merged into one patient record without user notifica…
2023-03-02 Class II Ongoing Z-1292-2023 Cirq Arm System 2.0 — Risk of mechanical instability due to potential manufacturing error of the device
2023-02-14 Class II Ongoing Z-1259-2023 Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F. — Deep Inspiration Breath Hold (DIBH) functionality may not work as specified when based on a standard-workflow Treatment Template
2022-02-25 Class II Ongoing Z-0733-2022 ExacTrac Dynamic software model numbers: 20910-01, ETD Positioning and Moni. 1.0.0 INST; 20910-01A, ETD Positioning … — The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs.
2021-05-14 Class II Terminated Z-1846-2021 ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to p… — Display of potential patient movement might be delayed to the user for high dose treatments.
2021-03-01 Class II Terminated Z-1185-2021 ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). — In case of a failed automatic marker detection, a software error causes parts of the display to incorrectly behave as if the current patient position is within…
2020-08-31 Class II Terminated Z-0056-2021 Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Prod… — Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.
2020-08-20 Class II Terminated Z-2925-2020 Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and … — Holding force of the Positioning Arm can be reduced by prolonged non-use.
2020-07-16 Class II Terminated Z-2793-2020 BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655 — Incorrect manufacturer calibration
2020-07-16 Class II Terminated Z-2792-2020 BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 0405648… — Incorrect manufacturer calibration
Filings

All 510(k) clearances (43)

Date K-number Device Code Class Specialty
2025-10-16 K252476 Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout LLZ Class II Radiology
2025-09-12 K252562 Spine & Trauma Navigation Instruments OLO Class II Neurology
2025-07-22 K243432 Vascular Navigation PAD 2.0; Navigation Software Vascular PAD OWB — —
2025-06-23 K243142 Cranial 4Pi Immobilization IYE — —
2025-06-17 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 Class II Radiology
2025-06-13 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 Class II Radiology
2025-06-04 K243810 TraumaCad Neo (1.1) QIH Class II Radiology
2025-05-16 K242569 Mixed Reality Spine Navigation SBF Class II Neurology
2025-01-28 K243698 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 HAW — —
2024-07-24 K240431 ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface IYE — —
2024-05-23 K240701 Drill Guide; Drill Bit; Spine & Trauma Navigation OLO Class II Neurology
2024-05-21 K232759 Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout LLZ Class II Radiology
2024-03-20 K234047 Automatic Registration OLO Class II Neurology
2023-11-20 K231498 TraumaCad Neo LLZ Class II Radiology
2023-09-09 K223864 Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial HAW — —
2023-08-02 K223553 Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine OLO Class II Neurology
2023-07-21 K223288 Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI HAW — —
2023-07-14 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 Class II Radiology
2023-05-11 K231052 ExacTrac Dynamic 1.1.2 IYE — —
2023-04-27 K223734 ENT EM PGW — —
2023-04-19 K223552 Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial HAW — —
2023-03-14 K223279 RT Elements (4.0) MUJ Class II Radiology
2022-10-27 K222966 Cirq Arm System (2.0);Alignment System Spine OLO Class II Neurology
2022-09-08 K213989 Cranial EM System HAW — —
2022-08-30 K221618 Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System OLO Class II Neurology
2022-06-03 K220652 Knee 3 OLO Class II Neurology
2022-04-29 K220338 ExacTrac Dynamic IYE — —
2022-04-19 K213930 Brainlab Elements Guide XT, Guide 3.0 QQC Class II Neurology
2022-04-13 K212245 Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning OLO Class II Neurology
2021-12-16 K212420 Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio LLZ Class II Radiology
2021-11-12 K210989 Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System HAW — —
2021-11-03 K211544 Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization HAW — —
2021-07-22 K211939 ExacTrac Dynamic IYE — —
2021-04-09 K203681 RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review MUJ Class II Radiology
2021-03-18 K203679 Automatic Registration OLO Class II Neurology
2021-01-29 K201752 Disposable Pre-calibrated Suction HAW — —
2020-12-23 K202320 CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System OLO Class II Neurology
2020-11-12 K203173 ExacTrac Dynamic IYE — —
2020-10-08 K192703 Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update HAW — —
2020-08-19 K202050 Cranial 4Pi Immobilization IYE — —
2020-07-13 K201276 ExacTrac Dynamic IYE — —
2020-06-02 K193307 HIP7 OLO Class II Neurology
2020-01-23 K191014 Elements Viewer LLZ Class II Radiology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence