ClearanceBrief
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

CodeDeviceRecords
HAWNeurological Stereotaxic Instrument68
IYEAccelerator, Linear, Medical39
OLOOrthopedic Stereotaxic Instrument27
MUJSystem, Planning, Radiation Therapy Treatment18
LLZSystem, Image Processing, Radiological17
JAICouch, Radiation Therapy, Powered3
LHNSystem, Radiation Therapy, Charged-Particle, Medical3
QIHAutomated Radiological Image Processing Software3
JAKSystem, X-Ray, Tomography, Computed2
HBLHolder, Head, Neurosurgical (Skull Clamp)1
IWYHolder, Head, Radiographic1
IYHGenerator, Dermatological (Grenz Ray), Therapeutic X-Ray1
KXKSource, Brachytherapy, Radionuclide1
LMADigitizer, Image, Radiological1
OWBInterventional Fluoroscopic X-Ray System1
PGWEar, Nose, And Throat Stereotaxic Instrument1
QQCBrain Stimulation Programming Planning Software.1
SBFOrthopedic Augmented Reality1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 16, 2025K252476Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
Brainlab AG, DE
LLZ
Sep 12, 2025K252562Spine & Trauma Navigation Instruments
Brainlab AG, DE
OLO
Jul 22, 2025K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PAD
Brainlab AG, DE
OWB
Jun 23, 2025K243142Cranial 4Pi Immobilization
Brainlab AG, DE
IYE
Jun 17, 2025K250440RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial
Brainlab AG, DE
MUJ
Jun 13, 2025K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elem
Brainlab AG, DE
QIH
Jun 4, 2025K243810TraumaCad Neo (1.1)
Brainlab , Ltd., IL
QIH
May 16, 2025K242569Mixed Reality Spine Navigation
Brainlab AG, DE
SBF
Jan 28, 2025K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignm
Brainlab AG, DE
HAW
Jul 24, 2024K240431ExacTrac Dynamic (2.0); ExacTrac Dynamic Surface
Brainlab AG, DE
IYE
May 23, 2024K240701Drill Guide; Drill Bit; Spine & Trauma Navigation
Brainlab AG, DE
OLO
May 21, 2024K232759Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
Brainlab AG, DE
LLZ
Mar 20, 2024K234047Automatic Registration
Brainlab AG, DE
OLO
Nov 20, 2023K231498TraumaCad Neo
Brainlab , Ltd., IL
LLZ
Sep 9, 2023K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cr
Brainlab AG, DE
HAW
Aug 2, 2023K223553Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine
Brainlab AG, DE
OLO
Jul 21, 2023K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registra
Brainlab AG, DE
HAW
Jul 14, 2023K223106Brainlab 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, 2023K231052ExacTrac Dynamic 1.1.2
Brainlab AG, DE
IYE
Apr 27, 2023K223734ENT EM
Brainlab AG, DE
PGW
Apr 19, 2023K223552Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Plan
Brainlab AG, DE
HAW
Mar 14, 2023K223279RT Elements (4.0)
Brainlab AG, DE
MUJ
Oct 27, 2022K222966Cirq Arm System (2.0);Alignment System Spine
Brainlab AG, DE
OLO
Sep 8, 2022K213989Cranial EM System
Brainlab AG, DE
HAW
Aug 30, 2022K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Softw
Brainlab AG, DE
OLO
Jun 3, 2022K220652Knee 3
Brainlab AG, DE
OLO
Apr 29, 2022K220338ExacTrac Dynamic
Brainlab AG, DE
IYE
Apr 19, 2022K213930Brainlab Elements Guide XT, Guide 3.0
Brainlab AG, DE
QQC
Apr 13, 2022K212245Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software
Brainlab AG, DE
OLO
Dec 16, 2021K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainl
Brainlab AG, DE
LLZ
Nov 12, 2021K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic
Brainlab AG, DE
HAW
Nov 3, 2021K211544Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization
Brainlab AG, DE
HAW
Jul 22, 2021K211939ExacTrac Dynamic
Brainlab AG, DE
IYE
Apr 9, 2021K203681RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review
Brainlab AG, DE
MUJ
Mar 18, 2021K203679Automatic Registration
Brainlab AG, DE
OLO
Jan 29, 2021K201752Disposable Pre-calibrated Suction
Brainlab AG, DE
HAW
Dec 23, 2020K202320CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIR
Brainlab AG, DE
OLO
Nov 12, 2020K203173ExacTrac Dynamic
Brainlab AG, DE
IYE
Oct 8, 2020K192703Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial
Brainlab AG, DE
HAW
Aug 19, 2020K202050Cranial 4Pi Immobilization
Brainlab AG, DE
IYE
Jul 13, 2020K201276ExacTrac Dynamic
Brainlab AG, DE
IYE
Jun 2, 2020K193307HIP7
Brainlab AG, DE
OLO
Jan 23, 2020K191014Elements Viewer
Brainlab AG, DE
LLZ
Sep 6, 2019K190250Microscope Navigation
Brainlab AG, DE
HAW
Aug 29, 2019K183605Spine & Trauma Navigation
Brainlab AG, DE
OLO
Jun 11, 2019K191285Spine & Trauma Navigation
Brainlab AG, DE
OLO
Apr 25, 2019K190042Brainlab Elements Image Fusion Angio
Brainlab AG, DE
LLZ
Apr 12, 2019K190664RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
Brainlab AG, DE
MUJ
Mar 1, 2018K172820Microscope Navigation Software
Brainlab AG, DE
HAW
Sep 26, 2017K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM
Brainlab AG, DE
LLZ

Newest 50 of 142.

Latest recalls

DateFirm and productCodeLinked 510(k)
Mar 18, 2025Brainlab AG
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Open, Classified
LLZK232759
Mar 28, 2023Brainlab AG
Cirq Arm System 2.0
Open, Classified
OLOK222966
Mar 16, 2023Brainlab AG
Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
Open, Classified
IYEK220338
Feb 25, 2022Brainlab 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
IYEK211939
May 14, 2021Brainlab 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
IYEK203173
Mar 1, 2021Brainlab AG
ExacTrac Dynamic (Medical Charged-Particle Radiation Therapy System).
Terminated
IYEK201276
Aug 31, 2020Brainlab 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
HAWK092467
Aug 20, 2020Brainlab 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
OLOK183605
Jul 16, 2020Brainlab AG
BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
Terminated
OLOK183605
Jul 16, 2020Brainlab AG
BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
Terminated
OLOK183605
Sep 25, 2019Brainlab 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
LMANone listed
Apr 15, 2019Brainlab 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
HAWK070106
Mar 11, 2019Brainlab 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
MUJK142108
K170750
Feb 14, 2018Brainlab 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
IYEK120789
Nov 16, 2017Brainlab AG
Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
Terminated
HAWK070106
Nov 3, 2017Brainlab 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
IYEK122451
Jul 28, 2017Brainlab 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
JAKK160126
Oct 27, 2016Brainlab AG
Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
Terminated
OLOK102990
May 4, 2016Brainlab AG
ExacTrac Vero is a Patient Positioning System for Radiation therapy.
Terminated
IYEK122451
Jan 19, 2016Brainlab 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
HAWK092467
Nov 17, 2015Brainlab 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
HAWK070106
Nov 5, 2015Brainlab 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
MUJK142108
Nov 5, 2015Brainlab 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
MUJK142108
Sep 21, 2015Brainlab 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
LLZK093117
Aug 21, 2015Brainlab 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
IYEK120789
Aug 18, 2015Brainlab 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
HAWK100038
May 6, 2015Brainlab 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
IYHK120789
Mar 25, 2015Brainlab AG
ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
Terminated
IYEK120789
Feb 26, 2015Brainlab 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
OLOK122011
Jan 15, 2015Brainlab 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
MUJK053584
K080888 +1
Jan 15, 2015Brainlab 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
MUJK053584
K080888 +1
Aug 13, 2014Brainlab 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
HAWK070106
Aug 4, 2014Brainlab 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
IYEK120789
Jul 30, 2014Brainlab 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
LLZK093117
Jun 3, 2014Brainlab AG
ExacTrac 5.5, an Image Processing System used for patient positioning for radiation therapy or radiosurgery.
Terminated
IYEK072506
Apr 25, 2014Brainlab 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
IYEK120789
Apr 17, 2014Brainlab AG
Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264
Terminated
HAWK070106
Feb 10, 2014Brainlab 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
HAWK053159
Aug 26, 2013Brainlab 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
IYEK073018
Sep 20, 2009Brainlab 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
MUJK002509
K080888 +2
Jul 2, 2009Brainlab 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
IYEK004022
Jul 2, 2009Brainlab 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
IYEK020860
Jul 2, 2009Brainlab 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
IYEK004022
Jul 2, 2009Brainlab 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
IYEK970586
Sep 17, 2008Brainlab 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
MUJK023651
Jul 3, 2007Brainlab 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
IWYK053584
Jul 27, 2006Brainlab 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
JAIK033316
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