Brainlab, Inc.
Westchester, IL, US
BRAINLAB, INC. appears in FDA device records in Westchester, IL. FDA records list 146 510(k) clearances between and , no PMA records and 4 registered establishments. As of , FDA records show 54 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Brainlab, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Brainlab SEregistration, 510(k)
- Mobius Imaging, LLCregistration, 510(k), enforcement report, recall
510(k) clearance history
Showing 50 of 146FDA records hold 146 510(k) clearances for Brainlab, Inc. between 1992 and 2026. The busiest year on record is 2004, with 10. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 2 |
| 1996 | 1 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 3 |
| 2000 | 3 |
| 2001 | 7 |
| 2002 | 7 |
| 2003 | 3 |
| 2004 | 10 |
| 2005 | 6 |
| 2006 | 10 |
| 2007 | 7 |
| 2008 | 6 |
| 2009 | 4 |
| 2010 | 3 |
| 2011 | 6 |
| 2012 | 5 |
| 2013 | 2 |
| 2014 | 3 |
| 2016 | 2 |
| 2017 | 2 |
| 2018 | 2 |
| 2019 | 5 |
| 2020 | 7 |
| 2021 | 7 |
| 2022 | 7 |
| 2023 | 9 |
| 2024 | 4 |
| 2025 | 9 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254010 | ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface | IYE | Substantially Equivalent | |
| K252476 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | LLZ | Substantially Equivalent | |
| K252562 | Spine & Trauma Navigation Instruments | OLO | Substantially Equivalent | |
| K243432 | Vascular Navigation PAD 2.0; Navigation Software Vascular PAD | OWB | Substantially Equivalent | |
| K243142 | Cranial 4Pi Immobilization | IYE | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K243810 | TraumaCad Neo (1.1) | QIH | Substantially Equivalent | |
| K242569 | Mixed Reality Spine Navigation | SBF | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K240431 | ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface | IYE | Substantially Equivalent | |
| K240701 | Drill Guide; Drill Bit; Spine & Trauma Navigation | OLO | Substantially Equivalent | |
| K232759 | Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout | LLZ | Substantially Equivalent | |
| K234047 | Automatic Registration | OLO | Substantially Equivalent | |
| K231498 | TraumaCad Neo | LLZ | Substantially Equivalent | |
| K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial | HAW | Substantially Equivalent | |
| K223553 | Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine | OLO | Substantially Equivalent | |
| K223288 | Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI | HAW | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K231052 | ExacTrac Dynamic 1.1.2 | IYE | Substantially Equivalent | |
| K223734 | ENT EM | PGW | Substantially Equivalent | |
| K223552 | Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial | HAW | Substantially Equivalent | |
| K223279 | RT Elements (4.0) | MUJ | Substantially Equivalent | |
| K222966 | Cirq Arm System (2.0);Alignment System Spine | OLO | Substantially Equivalent | |
| K213989 | Cranial EM System | HAW | Substantially Equivalent | |
| K221618 | Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System | OLO | Substantially Equivalent | |
| K220652 | Knee 3 | OLO | Substantially Equivalent | |
| K220338 | ExacTrac Dynamic | IYE | Substantially Equivalent | |
| K213930 | Brainlab Elements Guide XT, Guide 3.0 | QQC | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K212420 | Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio | LLZ | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K211544 | Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization | HAW | Substantially Equivalent | |
| K211939 | ExacTrac Dynamic | IYE | Substantially Equivalent | |
| K203681 | RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review | MUJ | Substantially Equivalent | |
| K203679 | Automatic Registration | OLO | Substantially Equivalent | |
| K201752 | Disposable Pre-calibrated Suction | HAW | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K203173 | ExacTrac Dynamic | IYE | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K202050 | Cranial 4Pi Immobilization | IYE | Substantially Equivalent | |
| K201276 | ExacTrac Dynamic | IYE | Substantially Equivalent | |
| K193307 | HIP7 | OLO | Substantially Equivalent | |
| K191014 | Elements Viewer | LLZ | Substantially Equivalent | |
| K190250 | Microscope Navigation | HAW | Substantially Equivalent | |
| K183605 | Spine & Trauma Navigation | OLO | Substantially Equivalent | |
| K191285 | Spine & Trauma Navigation | OLO | Substantially Equivalent | |
| K190042 | Brainlab Elements Image Fusion Angio | LLZ | Substantially Equivalent | |
| K190664 | RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review | MUJ | Substantially Equivalent | |
| K180393 | AIRO Computed Tomography (CT) X-ray System | JAK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8043933 | 3002619595 | BRAINLAB SE | Olof-Palme-Strasse 9, Munich Bavaria 81829 DE | 2026 | and 28 more, listed in full below |
| 2248788 | 3000206463 | BRAINLAB, INC. | 5 Westbrook Corporate Ctr Ste 1000, WESTCHESTER, IL 60154 US | 2026 | No device listings on this registration |
| 3005225421 | 3005225421 | Brainlab Ltd. | 35 Efal Street, PETACH-TIKVA Central 4951132 IL | 2026 | |
| 3010151377 | 3010151377 | MOBIUS IMAGING, LLC | 2 Shaker Road, Shirley, MA 01464 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IYEAccelerator, Linear, Medical
- QIHAutomated Radiological Image Processing Software
- QQCBrain Stimulation Programming Planning Software.
- KQMCamera, Surgical And Accessories
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- HCACatheter, Ventricular
- JAICouch, Radiation Therapy, Powered
- DXJDisplay, Cathode-Ray Tube, Medical
- PUIDrape, Surgical, Exempt
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
- PGWEar, Nose, And Throat Stereotaxic Instrument
- IKNElectromyograph, Diagnostic
- HBMHeadrest, Neurosurgical
- HBLHolder, Head, Neurosurgical (Skull Clamp)
- OWBInterventional Fluoroscopic X-Ray System
- OUGMedical Device Data System
- HAWNeurological Stereotaxic Instrument
- SBFOrthopedic Augmented Reality
- OLOOrthopedic Stereotaxic Instrument
- IXGPhantom, Anthropomorphic, Radiographic
- QKBRadiological Image Processing Software For Radiation Therapy
- HXXScrewdriver
- GXLScrewdriver, Skullplate
- KXKSource, Brachytherapy, Radionuclide
- FOXStand, Infusion
- GWFStimulator, Electrical, Evoked Response
- LMDSystem, Digital Image Communications, Radiological
- LLZSystem, Image Processing, Radiological
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- MUJSystem, Planning, Radiation Therapy Treatment
- LHNSystem, Radiation Therapy, Charged-Particle, Medical
- JACSystem, X-Ray, Film Marking, Radiographic
- JAKSystem, X-Ray, Tomography, Computed
- IXQTable, Radiographic, Stationary Top
- JEATable, Surgical With Orthopedic Accessories, Ac-Powered
- ITXTransducer, Ultrasonic, Diagnostic
- FSMTray, Surgical, Instrument
- HXCWrench
Recall records
Showing 25 of 54| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1041-2026 | Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System. | AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. | Class II | Open, Classified | |
| Z-1040-2026 | Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System. | AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. | Class II | Open, Classified | |
| 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 notification. | Class II | Open, Classified | |
| Z-1292-2023 | Cirq Arm System 2.0 | Risk of mechanical instability due to potential manufacturing error of the device | Class II | Open, Classified | |
| 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 | Class II | Open, Classified | |
| Z-0957-2023 | MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system. | Stryker received one report of an injury to an untrained user that occurred while the untrained user was moving an Airo TruCT unit in reverse. The firm will increase visibility of instructions for users to consider when transporting the unit in reverse by providing labels to be affixed onto the AIRO. | Class II | Open, Classified | |
| Z-0344-2023 | MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography (CT) system, software version 2.1.1 | Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. The firm is notifying customers with units whose battery monitoring systems were bypassed to charge the batteries; the batteries in these units require replacing. | Class II | Terminated | |
| Z-0733-2022 | 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 20910-01C ETD Positioning and Moni. 1.0.3 INST. | The yaw angle may be incorrect for CBCT positioning workflows using setup beams with Varian LINACs. | Class II | Open, Classified | |
| Z-1846-2021 | 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 medical accelerator for stereotactic radiosurgery or radiotherapy procedures, to monitor the patient position, and to provide a beam hold signal in case of a deviations in order to treat lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated. | Display of potential patient movement might be delayed to the user for high dose treatments. | 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 predefined tolerances and may allow the user to proceed to treatment despite potentially exceeding shift values. | 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 - Product Usage: intended to be an intra-operative image guided localization system to enable minimally invasive surgery. | Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width. | 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 56000A) | Holding force of the Positioning Arm can be reduced by prolonged non-use. | 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 | Class II | Terminated | |
| Z-2792-2020 | BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011 | Incorrect manufacturer calibration | Class II | Terminated | |
| Z-0176-2020 | 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 25100-12 - PATIENT DATA MANAGER 2.3 INSTALLER 25100-12A - PATIENT DATA MANAGER 2.3.1 INSTALLER 25100-13 - PATIENT DATA MANAGER 2.3 LICENSE 25100-12B - PATIENT DATA MANAGER 2.4.0 INSTALLER 25100-13A - PATIENT DATA MANAGER 2.4 LICENSE 25100-12C - PATIENT DATA MANAGER 2.5.0 INSTALLER 25100-12D - PATIENT DATA MANAGER 2.5.1 INSTALLER 25100-13B - PATIENT DATA MANAGER 2.5 LICENSE used in combination with iPlan CMF/Cranial/ENT/Spine 3.0.5, 3.0.6. Product Usage: Patient Data Manager is intended to load patient data from and export patient data to connected network locations (like file shares and PACS) and removable media. Furthermore, the software is intended to start other applications (like Brainlab planning and navigation applications) and to route applications and connected video sources to displays attached to the system that are running Patient Data Manager. The software is also intended to connect two Brainlab systems to each other via network. | The Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1 (if used in combination with iPlan CMF/Cranial/ENT/Spine 3.0.5, 3.0.6) that may lead to shifts applied to segmentation objects in iPlan being not reflected when exported into DICOM under specific circumstances. | Class II | Terminated | |
| Z-1205-2019 | 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 and 1.5.0 - Spine SRS 1.0.0 and 1.5.0 - Multiple Brain Mets SRS 1.5.0 - RT QA 1.0.0 and 1.5.0 Product Usage: The 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. | There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when using the Pencil Beam algorithm on the GPU (graphics card), as is the default system setting. | Class II | Terminated | |
| Z-1082-2019 | 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-guided localization system to enable minimally invasive surgery. | In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal (ACS) view representation with fixed planes in the image reconstruction (the not-updated ACS view ), instead of displaying the desirable view representation Inline View , which is commonly used for navigating invasive instruments at the spine. This could lead the surgeon to be unable to determine the position of the navigated instrument. This might occur after a crash restore or after changing between different navigation workflows during the same patient treatment. | Class I | Terminated | |
| Z-2991-2018 | AIRO Mobile CT System Model # MobiCT-32 | The Tube Current Modulation feature (Modulated Scans) is not working in AIRO systems with software version 2.0.0.0, and operators would not be able to detect this fault until after a scan is completed. | Class II | Terminated | |
| Z-1006-2018 | 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 procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment. | The usage of workflows that deviate from the recommended specifications in the User manual for ExacTrac Patient Positioning System (versions 6.0, 6.1, 6.2, 6.5) with Auxiliary Device Interface (ADI) and Varian Clinac or Varian TrueBeam, which may result in misinterpretation of beam authorization via ADI. | Class II | Terminated | |
| Z-0320-2018 | Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left | Due to a human error at a supplier, an unknown number of devices within one specific production lot of Brainlab DrapeLink Adapters (Left/Right) were not manufactured according to defined specifications. | Class II | Terminated | |
| Z-0172-2018 | 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 Vero system is intended to be used in conjunction with the MHI-TM2000 Radiation Therapy Linear Accelerator System manufactured by Mitsubishi Heavy Industries, Ltd. ExacTrac Vero uses the images received from the MHI-TM2000 linear accelerator for analyzing the current patient position and calculating - when applicable - a necessary correction shift. The correction shift is then exported to the MHI-TM2000 linear accelerator. The ExacTrac Vero system uses stereoscopic X-ray or Cone Beam CT registration and optical tracking of infrared reflective markers in order to localize and correct the patient position before and during treatment. Optionally ExacTrac Vero provides position data for the pan/tilt motion of the MHI-TM2000 gantry head to the MHITM2000 controller for continuous alignment of the beam orientation with a moving target. The position data is based on target detection via X-ray imaging and IR tracking of external surrogate markers. | Brainlab has internally detected that under specific conditions ExacTrac Vero may not correctly account for this ring angle correction during the calculation of the corresponding couch shift. This may result in the treatment couch not moving to the exact planned position resulting in a deviation between the planned and the treatment target position. This deviation may not be clearly visible to the user if no verification image of the patient position is acquired after this couch shift has been performed. | Class II | Terminated | |
| Z-0715-2018 | 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 pediatric patients and patients weighing over 400 lbs. (182 kg). | If the tilt-drive motor has an intermittent connection or broken encoder or sensor wire there is a risk of unintended or unpredictable device motion while the CT system is homing the axis at startup or preparing for a scan. | Class II | Terminated | |
| Z-0509-2018 | 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 pediatric patients and patients weighing over 400 lbs. (182 kg). | Risk of unintended motion while the AIRO system is in transport mode. | Class II | Terminated | |
| Z-0959-2017 | Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic | Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base with specific serial numbers might contain parts made from incorrect material and therefore not be suitable for reprocessing | Class II | Terminated | |
| Z-1929-2016 | ExacTrac Vero is a Patient Positioning System for Radiation therapy. | Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5 | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain