Brainlab AG - FDA 510(k) Cleared Devices
135
Total
135
Cleared
0
Denied
53 devices
Cleared
Feb 28, 2014
ADVANCED VIEWER
Radiology
177d
Cleared
Sep 28, 2012
EXACTRAC VERO
Radiology
46d
Cleared
Aug 14, 2012
EXACTRAC X-RAY X-RAY
Radiology
152d
Cleared
Jun 29, 2012
EXACTRAC ROBOTICS NOVALIS ROBOTICS
Radiology
129d
Cleared
May 07, 2012
IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW,...
Radiology
140d
Cleared
Mar 16, 2011
IPLAN RT
Radiology
133d
Cleared
Dec 11, 2009
DIGITAL LIGHTBOX
Radiology
70d
Cleared
Jun 24, 2008
IPLAN RT IMAGE
Radiology
85d
Cleared
Jun 11, 2008
MODEIFICATION TO IPLAN RT DOSE
Radiology
72d
Cleared
Apr 17, 2008
DIGITAL LIGHTBOX
Radiology
44d
Cleared
Jan 23, 2008
STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING,...
Radiology
90d
Cleared
Oct 26, 2007
EXACTRAC 5.5
Radiology
50d
Cleared
Oct 17, 2007
EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM
Radiology
84d
Cleared
Jul 12, 2006
IPLAN RT DOSE
Radiology
201d
Cleared
Feb 03, 2006
FRAMELESS RADIOSURGERY COMPONENTS
Radiology
49d
Cleared
Sep 30, 2005
IPLAN RT FIBERTRACKING
Radiology
46d
Cleared
Jul 22, 2004
PATXFER RT
Radiology
104d
Cleared
May 14, 2004
TABLE TILT DEVICE
Radiology
212d
Cleared
May 11, 2004
EXACTRAC 4.0 AND EXACTRAC X-RAY 6D
Radiology
67d
Cleared
Jan 21, 2004
INTUITION IMAGE
Radiology
160d
Cleared
Dec 19, 2003
EXACTRAC GATING
Radiology
66d
Cleared
Aug 12, 2002
PATXFER
Radiology
90d
Cleared
Jun 06, 2002
M3 (MICRO-MULTILEAF COLLIMATOR)
Radiology
80d
Cleared
Mar 26, 2002
M3 (MIRCO-MULTILEAF COLLIMATOR
Radiology
454d
Cleared
Jul 31, 2001
EXAC TRAC 2.0 (NOVALIS BODY MODULE)
Radiology
285d