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
K110204 01/24/2011 BRAINLAB TRAUMA 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
K072573 09/12/2007 VECTORVISION HIP AND HIP SR BRAINLAB AG
K072716 09/12/2007 VECTOR VISION HIP BRAINLAB AG
K080888 03/31/2008 MODEIFICATION TO IPLAN RT DOSE BRAINLAB AG
K042391 09/02/2004 KOLIBRI IMAGE GUIDED SURGERY SYSTEM BRAINLAB AG
K083483 11/24/2008 BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED 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
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
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
K052213 08/15/2005 NAVIGATION SW HIP 3.1 ON CI BRAINLAB AG
K052220 08/15/2005 IPLAN RT FIBERTRACKING 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
K053159 11/14/2005 VECTORVISION SPINE BRAINLAB AG
K053164 11/14/2005 IPLAN FLOW 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
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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