FDA 510(k) Applications Submitted by BRAINLAB AG
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K092467 |
08/12/2009 |
VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED |
BRAINLAB AG |
| K183605 |
12/26/2018 |
Spine & Trauma Navigation |
Brainlab AG |
| K110204 |
01/24/2011 |
BRAINLAB TRAUMA |
BRAINLAB AG |
| K190250 |
02/07/2019 |
Microscope Navigation |
Brainlab AG |
| K120520 |
02/21/2012 |
EXACTRAC ROBOTICS NOVALIS ROBOTICS |
BRAINLAB AG |
| K120789 |
03/15/2012 |
EXACTRAC X-RAY X-RAY |
BRAINLAB AG |
| K141199 |
05/09/2014 |
QUENTRY DOSE REVIEW |
BRAINLAB AG |
| K101627 |
06/09/2010 |
IPLAN |
BRAINLAB AG |
| K122011 |
07/09/2012 |
NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP |
BRAINLAB AG |
| K122225 |
07/25/2012 |
STERILE RADIOLUCENT SKULL PINS |
BRAINLAB AG |
| K142108 |
08/04/2014 |
RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS |
BRAINLAB AG |
| K102251 |
08/09/2010 |
DASH KNEE |
BRAINLAB AG |
| K122451 |
08/13/2012 |
EXACTRAC VERO |
BRAINLAB AG |
| K172820 |
09/18/2017 |
Microscope Navigation Software |
Brainlab AG |
| K102990 |
10/08/2010 |
BRAINLAB KNEE |
BRAINLAB AG |
| K113732 |
12/19/2011 |
IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) |
BRAINLAB AG |
| K072716 |
09/12/2007 |
VECTOR VISION HIP |
BRAINLAB AG |
| K072573 |
09/12/2007 |
VECTORVISION HIP AND HIP SR |
BRAINLAB AG |
| K080888 |
03/31/2008 |
MODEIFICATION TO IPLAN RT DOSE |
BRAINLAB AG |
| K193307 |
11/29/2019 |
HIP7 |
Brainlab AG |
| K220652 |
03/07/2022 |
Knee 3 |
Brainlab AG |
| K210989 |
04/02/2021 |
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 |
Brainlab AG |
| K201276 |
05/13/2020 |
ExacTrac Dynamic |
Brainlab AG |
| K211544 |
05/19/2021 |
Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization |
Brainlab AG |
| K221618 |
06/03/2022 |
Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System |
Brainlab AG |
| K211939 |
06/23/2021 |
ExacTrac Dynamic |
Brainlab AG |
| K201752 |
06/26/2020 |
Disposable Pre-calibrated Suction |
Brainlab AG |
| K212245 |
07/19/2021 |
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 S |
Brainlab AG |
| K202050 |
07/24/2020 |
Cranial 4Pi Immobilization |
Brainlab AG |
| K212420 |
08/04/2021 |
Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio |
Brainlab AG |
| K192703 |
09/27/2019 |
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 |
Brainlab AG |
| K203173 |
10/26/2020 |
ExacTrac Dynamic |
Brainlab AG |
| K213930 |
12/16/2021 |
Brainlab Elements Guide XT, Guide 3.0 |
Brainlab AG |
| K203681 |
12/17/2020 |
RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review |
Brainlab AG |
| K203679 |
12/17/2020 |
Automatic Registration |
Brainlab AG |
| K213989 |
12/20/2021 |
Cranial EM System |
Brainlab AG |
| K202320 |
08/17/2020 |
CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System |
Brainlab AG |
| K223288 |
10/25/2022 |
Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI |
Brainlab AG |
| K223734 |
12/13/2022 |
ENT EM |
Brainlab AG |
| K223864 |
12/23/2022 |
Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial |
Brainlab AG |
| K042391 |
09/02/2004 |
KOLIBRI IMAGE GUIDED SURGERY SYSTEM |
BRAINLAB AG |
| K191285 |
05/13/2019 |
Spine & Trauma Navigation |
Brainlab AG |
| K223106 |
09/30/2022 |
Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) |
Brainlab AG |
| K083483 |
11/24/2008 |
BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED |
BRAINLAB AG |
| K191014 |
04/17/2019 |
Elements Viewer |
Brainlab AG |
| K080678 |
03/10/2008 |
UNI-KNEE 2.0 |
BRAINLAB AG |
| K073615 |
12/26/2007 |
BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED |
BRAINLAB AG |
| K190042 |
01/09/2019 |
Brainlab Elements Image Fusion Angio |
Brainlab AG |
| K070106 |
01/11/2007 |
VV FLUORO 3D |
BRAINLAB AG |
| K040368 |
02/13/2004 |
VECTORVISION HIP 3.0 |
BRAINLAB AG |
| K060468 |
02/23/2006 |
VECTORVISION HIP |
BRAINLAB AG |
| K020631 |
02/27/2002 |
IPLAN |
BRAINLAB AG |
| K070556 |
02/27/2007 |
BRAINSUITE NET |
BRAINLAB AG |
| K040585 |
03/05/2004 |
EXACTRAC 4.0 AND EXACTRAC X-RAY 6D |
BRAINLAB AG |
| K170750 |
03/13/2017 |
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review |
Brainlab AG |
| K190664 |
03/15/2019 |
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review |
Brainlab AG |
| K060727 |
03/17/2006 |
VECTORVISION HIP |
BRAINLAB AG |
| K170816 |
03/20/2017 |
Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM |
Brainlab AG |
| K080886 |
03/31/2008 |
IPLAN RT IMAGE |
BRAINLAB AG |
| K021306 |
04/24/2002 |
VECTORVISION CT-FREE KNEE |
BRAINLAB AG |
| K041330 |
05/19/2004 |
IPLAN! FLOW |
BRAINLAB AG |
| K041899 |
07/14/2004 |
VECTORVISION UNI-KNEE |
BRAINLAB AG |
| K062086 |
07/21/2006 |
NAVIVISION |
BRAINLAB AG |
| K082060 |
07/21/2008 |
CRANIAL IMAGE GUIDED SURGERY SYSTEM |
BRAINLAB AG |
| K072046 |
07/25/2007 |
EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM |
BRAINLAB AG |
| K012448 |
08/01/2001 |
VECTORVISION TRAUMA |
BRAINLAB AG |
| K052220 |
08/15/2005 |
IPLAN RT FIBERTRACKING |
BRAINLAB AG |
| K052213 |
08/15/2005 |
NAVIGATION SW HIP 3.1 ON CI |
BRAINLAB AG |
| K072506 |
09/06/2007 |
EXACTRAC 5.5 |
BRAINLAB AG |
| K042513 |
09/15/2004 |
VECTORVISION OSTEOTOMY |
BRAINLAB AG |
| K042512 |
09/15/2004 |
VECTORVISION ACL |
BRAINLAB AG |
| K042543 |
09/20/2004 |
IPLAN! DIGITAL TEMPLATING |
BRAINLAB AG |
| K042721 |
10/01/2004 |
KOLIBRI SPINE |
BRAINLAB AG |
| K093117 |
10/02/2009 |
DIGITAL LIGHTBOX |
BRAINLAB AG |
| K093118 |
10/02/2009 |
BRAINLAB KNEE ARTHROSCOPY |
BRAINLAB AG |
| K033287 |
10/14/2003 |
EXACTRAC GATING |
BRAINLAB AG |
| K033316 |
10/15/2003 |
TABLE TILT DEVICE |
BRAINLAB AG |
| K073018 |
10/25/2007 |
STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT |
BRAINLAB AG |
| K023651 |
10/30/2002 |
VECTORVISION CRANIAL/ENT |
BRAINLAB AG |
| K083310 |
11/10/2008 |
SPINE & TRAUMA ICT |
BRAINLAB AG |
| K053164 |
11/14/2005 |
IPLAN FLOW |
BRAINLAB AG |
| K053159 |
11/14/2005 |
VECTORVISION SPINE |
BRAINLAB AG |
| K053500 |
12/16/2005 |
FRAMELESS RADIOSURGERY COMPONENTS |
BRAINLAB AG |
| K153653 |
12/21/2015 |
DICOM Viewer |
Brainlab AG |
| K053584 |
12/23/2005 |
IPLAN RT DOSE |
BRAINLAB AG |
| K220338 |
02/07/2022 |
ExacTrac Dynamic |
Brainlab AG |
| K231052 |
04/13/2023 |
ExacTrac Dynamic 1.1.2 |
Brainlab AG |
| K222966 |
09/27/2022 |
Cirq Arm System (2.0);Alignment System Spine |
Brainlab AG |
| K223279 |
10/24/2022 |
RT Elements (4.0) |
Brainlab AG |
| K223552 |
11/25/2022 |
Brainlab Elements û Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial |
Brainlab AG |
| K223553 |
11/25/2022 |
Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine |
Brainlab AG |
| K020860 |
03/18/2002 |
M3 (MICRO-MULTILEAF COLLIMATOR) |
BRAINLAB AG |
| K021583 |
05/14/2002 |
PATXFER |
BRAINLAB AG |
| K012564 |
08/09/2001 |
MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM |
BRAINLAB AG |
| K002509 |
08/15/2000 |
NOVALIS (SHAPED BEAM SURGERY SYSTEM) |
BRAINLAB AG |
| K003589 |
11/20/2000 |
VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT |
BRAINLAB AG |
| K014256 |
12/26/2001 |
KOLIBRI IGS SYSTEMS |
BRAINLAB AG |
| K004022 |
12/27/2000 |
M3 (MIRCO-MULTILEAF COLLIMATOR |
BRAINLAB AG |
| K994413 |
12/29/1999 |
BRAINSCAN |
BRAINLAB AG |
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