FDA 510(k) Applications Submitted by Rainer Birkenbach
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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 |
| K010602 |
02/28/2001 |
VECTORVISION HIP |
BRAINLAB, AG |
| K010612 |
03/01/2001 |
VECTORVISION KNEE |
BRAINLAB, AG |
| K080608 |
03/04/2008 |
DIGITAL LIGHTBOX |
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 |
| K010968 |
04/02/2001 |
VECTORVISION CT/FLUORO |
BRAINLAB, AG |
| K040931 |
04/09/2004 |
PATXFER RT |
BRAINLAB, AG |
| K021306 |
04/24/2002 |
VECTORVISION CT-FREE KNEE |
BRAINLAB AG |
| K041330 |
05/19/2004 |
IPLAN! FLOW |
BRAINLAB AG |
| K031770 |
06/09/2003 |
CI TKR/UKR |
BRAINLAB, AG |
| K041703 |
06/22/2004 |
IPLAN! |
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 |
| K032511 |
08/14/2003 |
INTUITION IMAGE |
BRAINLAB, AG |
| K062358 |
08/14/2006 |
MODIFICATION TO 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 |
| K042512 |
09/15/2004 |
VECTORVISION ACL |
BRAINLAB AG |
| K042513 |
09/15/2004 |
VECTORVISION OSTEOTOMY |
BRAINLAB AG |
| K042543 |
09/20/2004 |
IPLAN! DIGITAL TEMPLATING |
BRAINLAB AG |
| K042721 |
10/01/2004 |
KOLIBRI SPINE |
BRAINLAB AG |
| K063028 |
10/02/2006 |
VECTORVISION HIP SR |
BRAINLAB, AG |
| K093118 |
10/02/2009 |
BRAINLAB KNEE ARTHROSCOPY |
BRAINLAB AG |
| K093117 |
10/02/2009 |
DIGITAL LIGHTBOX |
BRAINLAB AG |
| K033287 |
10/14/2003 |
EXACTRAC GATING |
BRAINLAB AG |
| K033316 |
10/15/2003 |
TABLE TILT DEVICE |
BRAINLAB AG |
| K052966 |
10/21/2005 |
CI KNEE, CI MI TKR |
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 |
| K053127 |
11/07/2005 |
IPLAN |
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 |
| K024192 |
11/20/2002 |
VECTORVISION FLUORO3D |
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 |
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