Company · DE
Brainlab AG
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2025. Name variants (Inc, Corp, punctuation) are merged.
142510(k) clearances (0 in 12 months)
47recalls (0 in 12 months)
46recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 68 |
| IYE | Accelerator, Linear, Medical | 39 |
| OLO | Orthopedic Stereotaxic Instrument | 27 |
| MUJ | System, Planning, Radiation Therapy Treatment | 18 |
| LLZ | System, Image Processing, Radiological | 17 |
| JAI | Couch, Radiation Therapy, Powered | 3 |
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 3 |
| QIH | Automated Radiological Image Processing Software | 3 |
| JAK | System, X-Ray, Tomography, Computed | 2 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 1 |
| IWY | Holder, Head, Radiographic | 1 |
| IYH | Generator, Dermatological (Grenz Ray), Therapeutic X-Ray | 1 |
| KXK | Source, Brachytherapy, Radionuclide | 1 |
| LMA | Digitizer, Image, Radiological | 1 |
| OWB | Interventional Fluoroscopic X-Ray System | 1 |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | 1 |
| QQC | Brain Stimulation Programming Planning Software. | 1 |
| SBF | Orthopedic Augmented Reality | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2025 | K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout Brainlab AG, DE | LLZ |
| Sep 12, 2025 | K252562 | Spine & Trauma Navigation Instruments Brainlab AG, DE | OLO |
| Jul 22, 2025 | K243432 | Vascular Navigation PAD 2.0; Navigation Software Vascular PAD Brainlab AG, DE | OWB |
| Jun 23, 2025 | K243142 | Cranial 4Pi Immobilization Brainlab AG, DE | IYE |
| Jun 17, 2025 | K250440 | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial Brainlab AG, DE | MUJ |
| Jun 13, 2025 | K243633 | Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elem Brainlab AG, DE | QIH |
| Jun 4, 2025 | K243810 | TraumaCad Neo (1.1) Brainlab , Ltd., IL | QIH |
| May 16, 2025 | K242569 | Mixed Reality Spine Navigation Brainlab AG, DE | SBF |
| Jan 28, 2025 | K243698 | Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignm Brainlab AG, DE | HAW |
| Jul 24, 2024 | K240431 | ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface Brainlab AG, DE | IYE |
| May 23, 2024 | K240701 | Drill Guide; Drill Bit; Spine & Trauma Navigation Brainlab AG, DE | OLO |
| May 21, 2024 | K232759 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout Brainlab AG, DE | LLZ |
| Mar 20, 2024 | K234047 | Automatic Registration Brainlab AG, DE | OLO |
| Nov 20, 2023 | K231498 | TraumaCad Neo Brainlab , Ltd., IL | LLZ |
| Sep 9, 2023 | K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cr Brainlab AG, DE | HAW |
| Aug 2, 2023 | K223553 | Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine Brainlab AG, DE | OLO |
| Jul 21, 2023 | K223288 | Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registra Brainlab AG, DE | HAW |
| Jul 14, 2023 | K223106 | Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image F Brainlab AG, DE | QIH |
| May 11, 2023 | K231052 | ExacTrac Dynamic 1.1.2 Brainlab AG, DE | IYE |
| Apr 27, 2023 | K223734 | ENT EM Brainlab AG, DE | PGW |
| Apr 19, 2023 | K223552 | Brainlab Elements Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Plan Brainlab AG, DE | HAW |
| Mar 14, 2023 | K223279 | RT Elements (4.0) Brainlab AG, DE | MUJ |
| Oct 27, 2022 | K222966 | Cirq Arm System (2.0);Alignment System Spine Brainlab AG, DE | OLO |
| Sep 8, 2022 | K213989 | Cranial EM System Brainlab AG, DE | HAW |
| Aug 30, 2022 | K221618 | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Softw Brainlab AG, DE | OLO |
| Jun 3, 2022 | K220652 | Knee 3 Brainlab AG, DE | OLO |
| Apr 29, 2022 | K220338 | ExacTrac Dynamic Brainlab AG, DE | IYE |
| Apr 19, 2022 | K213930 | Brainlab Elements Guide XT, Guide 3.0 Brainlab AG, DE | QQC |
| Apr 13, 2022 | K212245 | Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Brainlab AG, DE | OLO |
| Dec 16, 2021 | K212420 | Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainl Brainlab AG, DE | LLZ |
| Nov 12, 2021 | K210989 | Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Brainlab AG, DE | HAW |
| Nov 3, 2021 | K211544 | Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization Brainlab AG, DE | HAW |
| Jul 22, 2021 | K211939 | ExacTrac Dynamic Brainlab AG, DE | IYE |
| Apr 9, 2021 | K203681 | RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review Brainlab AG, DE | MUJ |
| Mar 18, 2021 | K203679 | Automatic Registration Brainlab AG, DE | OLO |
| Jan 29, 2021 | K201752 | Disposable Pre-calibrated Suction Brainlab AG, DE | HAW |
| Dec 23, 2020 | K202320 | CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIR Brainlab AG, DE | OLO |
| Nov 12, 2020 | K203173 | ExacTrac Dynamic Brainlab AG, DE | IYE |
| Oct 8, 2020 | K192703 | Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial Brainlab AG, DE | HAW |
| Aug 19, 2020 | K202050 | Cranial 4Pi Immobilization Brainlab AG, DE | IYE |
| Jul 13, 2020 | K201276 | ExacTrac Dynamic Brainlab AG, DE | IYE |
| Jun 2, 2020 | K193307 | HIP7 Brainlab AG, DE | OLO |
| Jan 23, 2020 | K191014 | Elements Viewer Brainlab AG, DE | LLZ |
| Sep 6, 2019 | K190250 | Microscope Navigation Brainlab AG, DE | HAW |
| Aug 29, 2019 | K183605 | Spine & Trauma Navigation Brainlab AG, DE | OLO |
| Jun 11, 2019 | K191285 | Spine & Trauma Navigation Brainlab AG, DE | OLO |
| Apr 25, 2019 | K190042 | Brainlab Elements Image Fusion Angio Brainlab AG, DE | LLZ |
| Apr 12, 2019 | K190664 | RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review Brainlab AG, DE | MUJ |
| Mar 1, 2018 | K172820 | Microscope Navigation Software Brainlab AG, DE | HAW |
| Sep 26, 2017 | K170816 | Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM Brainlab AG, DE | LLZ |
Newest 50 of 142.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2025 | Brainlab AG Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 Open, Classified |
LLZ | K232759 |
| Mar 28, 2023 | Brainlab AG Cirq Arm System 2.0 Open, Classified |
OLO | K222966 |
| Mar 16, 2023 | Brainlab AG Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F. Open, Classified |
IYE | K220338 |
| Feb 25, 2022 | Brainlab AG ExacTrac Dynamic software model numbers:
20910-01, ETD Positioning and Moni. 1.0.0 INST;
20910-01A, ETD Positioning and Moni. 1.0.1 INST;
20910-01B, ETD Positioning and Moni. 1.0.2 INST; and
20910-0 Open, Classified |
IYE | K211939 |
| May 14, 2021 | Brainlab AG ExacTrac Dynamic software, Model 20910-01B ETD Positioning and Monitoring Installer 1.0.2 - Product Usage: intended to position patients at an accurately defined point within the treatment beam of a m Terminated |
IYE | K203173 |
| Mar 1, 2021 | Brainlab AG ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System). Terminated |
IYE | K201276 |
| Aug 31, 2020 | Brainlab AG Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided localization system t Terminated |
HAW | K092467 |
| Aug 20, 2020 | Brainlab AG 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 56000A) Terminated |
OLO | K183605 |
| Jul 16, 2020 | Brainlab AG BRAINLAB Kick 2;
Model/catalogue (article) numbers for Kick: 18170; 18070
UDI (GTIN) for Kick: 04056481006655 Terminated |
OLO | K183605 |
| Jul 16, 2020 | Brainlab AG BRAINLAB Curve;
Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905
UDI (GTIN) for Curve: 04056481138011 Terminated |
OLO | K183605 |
| Sep 25, 2019 | Brainlab AG Patient Data Manager, Model/Catalogue Numbers:
25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY
25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY
25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY Terminated |
LMA | None listed |
| Apr 15, 2019 | Brainlab AG Spine & Trauma 3D Navigation 1.0 (subpart of the system Navigation Software Spine & Trauma 3D, Version 3.0 )
Intended Use The Spine & Trauma Navigation System is intended as an intraoperative image Terminated |
HAW | K070106 |
| Mar 11, 2019 | Brainlab AG RT Elements
Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected:
- Cranial SRS 1.0.0 Terminated |
MUJ | K142108 K170750 |
| Feb 14, 2018 | Brainlab AG ExacTrac versions 6.5 through 6.5 intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy Terminated |
IYE | K120789 |
| Nov 16, 2017 | Brainlab AG Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left Terminated |
HAW | K070106 |
| Nov 3, 2017 | Brainlab AG BRAINLAB EXACTRAC VERO, Model/Catalog Numbers:
46228 EXACTRAC VERO 3.5
46238 EXACTRAC VERO 3.5
46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3
46218 EXACTRAC VERO SW UPDATE 3.5.3 TO 3.5.4
The ExacTrac Terminated |
IYE | K122451 |
| Jul 28, 2017 | Brainlab AG AIRO Mobile CT System, Model Number: MobiCT-32
Product Usage:
The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding Terminated |
JAK | K160126 |
| Oct 27, 2016 | Brainlab AG Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic Terminated |
OLO | K102990 |
| May 4, 2016 | Brainlab AG ExacTrac Vero is a Patient Positioning System for Radiation therapy. Terminated |
IYE | K122451 |
| Jan 19, 2016 | Brainlab AG Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments.
The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localizatio Terminated |
HAW | K092467 |
| Nov 17, 2015 | Brainlab AG BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localizat Terminated |
HAW | K070106 |
| Nov 5, 2015 | Brainlab AG RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. Terminated |
MUJ | K142108 |
| Nov 5, 2015 | Brainlab AG RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions. Terminated |
MUJ | K142108 |
| Sep 21, 2015 | Brainlab AG Digital Lightbox, BrainLAB system, image processing, radiological
Product Usage:
The Patient Data Manager is a system intended for the display of medical images. The software can transfer images to a Terminated |
LLZ | K093117 |
| Aug 21, 2015 | Brainlab AG ExacTrac 6.0.x
Patient Positioning System, Radiation therapy.
Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic Terminated |
IYE | K120789 |
| Aug 18, 2015 | Brainlab AG Disposable Reflective Marker Spheres
The Disposable Reflective Marker Spheres used in conjunction with a stereotaxic instrument consisting of a rigid frame with a calibrated guide mechanism for preci Terminated |
HAW | K100038 |
| May 6, 2015 | Brainlab AG ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. Terminated |
IYH | K120789 |
| Mar 25, 2015 | Brainlab AG ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures.. Terminated |
IYE | K120789 |
| Feb 26, 2015 | Brainlab AG The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instr Terminated |
OLO | K122011 |
| Jan 15, 2015 | Brainlab AG iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial les Terminated |
MUJ | K053584 K080888 +1 |
| Jan 15, 2015 | Brainlab AG iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, an Terminated |
MUJ | K053584 K080888 +1 |
| Aug 13, 2014 | Brainlab AG Navigation Spine & Trauma 3D Version 2.0 and 2.1
Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passi Terminated |
HAW | K070106 |
| Aug 4, 2014 | Brainlab AG ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order t Terminated |
IYE | K120789 |
| Jul 30, 2014 | Brainlab AG Patient Data Manager 2.0 (Content manager 2.0, Patient Browser 4.0, DICOM Viewer 2.0) Brainlab Digital Lightbox. A system for the display of medical images. Model numbers 25100-05 and 25100-06. Terminated |
LLZ | K093117 |
| Jun 3, 2014 | Brainlab AG ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery. Terminated |
IYE | K072506 |
| Apr 25, 2014 | Brainlab AG ExacTrac 6.0 is a patient positioning and monitoring system.
Model/catalogue numbers:
20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE
49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3
49926B ET UPGRADE SOFTWARE 3. Terminated |
IYE | K120789 |
| Apr 17, 2014 | Brainlab AG Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264 Terminated |
HAW | K070106 |
| Feb 10, 2014 | Brainlab AG BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor sy Terminated |
HAW | K053159 |
| Aug 26, 2013 | Brainlab AG BRAINLAB; FRAMELESS SRS QA TARGET POINTER
Robotics is a device used to compensate rotational patient misalignment (roll and pitch) in a linear accelerator environment for stereotactic radiosurgery or Terminated |
IYE | K073018 |
| Sep 20, 2009 | Brainlab AG BrainLab Radiotherapy Treatment Planning Software;
Catalog number 20610 - Radiosurgery 3.0
Catalog number 20620 - Radiosurgery 3.5 and
Catalog number 20630 - Circular ARC SRS/SRT Planning.
The soft Terminated |
MUJ | K002509 K080888 +2 |
| Jul 2, 2009 | Brainlab AG BrainLAB M3 Micro-Multileaf-Collimator for Elekta/Philips Type III with MLC, model 41600-06, -6 A; BrainLAB AG, Acetylesterase 12, 85622 Edicendi, Germany.
The m MLC is intended to assist the radiat Terminated |
IYE | K004022 |
| Jul 2, 2009 | Brainlab AG BrainLab M3 Micro-Multileaf-Collimator for Siemens Mevatron Digital Type III with MLC, model 41600-5, -5 A; BrainLAB AG, Acetylesterase 12, 85622 Edicendi, Germany.
The m MLC is intended to assist th Terminated |
IYE | K020860 |
| Jul 2, 2009 | Brainlab AG BrainLab m3 Micro-Multileaf-Collimator for Varian Type III with MLC, model 41600-3; BrainLab AG, Kapellenstrasse 12, 85622 Feldkirchen, Germany.
The mMLC is intended to assist the radiation oncologis Terminated |
IYE | K004022 |
| Jul 2, 2009 | Brainlab AG BrainLab Micro-Multileaf-Collimator, model 41600; BrainLab AG, Kapellenstrasse 12, 85622 Feldkirchen, Germany.
The mMLC is intended to assist the radiation oncologist in the delivery of radiation to Terminated |
IYE | K970586 |
| Sep 17, 2008 | Brainlab AG VectorVision (VV) Sky Navigation Platform (19" Computer Rack); the 19" computer rack is a component of the VVsky Vario, BrainSUITE iMRI, BrainSUITE NET and BrainSUITE iCT systems; BrainLab AG, Kapell Terminated |
MUJ | K023651 |
| Jul 3, 2007 | Brainlab AG BrainLAB Target Positioner for Leksell Headring used with the iPlan RT Dose (versions 3.0, 3.0.1 and 3.0.2) and BrainSCAN (version 5.31) Radiotherapy Treatment Planning Software, ; BrainLab AG, Ammert Terminated |
IWY | K053584 |
| Jul 27, 2006 | Brainlab AG ExacTrac Robotics, sold alone as Robotic Tilt Module catalog 49720 and in a bundle as catalog 49700, for installation on the Varian Exact Couch, a component of the Novalis Shaped Beam Surgery System; Terminated |
JAI | K033316 |