Brainlab AG

Model/Catalog Number: 19061-03

Neurological Devices

2

No

Worldwide distribution: US (nationwide) including states of: NC, NY, OH, WI;and countries of: Austria, China, Germany, Italy, Japan, Malaysia, and Saudi Arabia.

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 passive marker sensor system to virtual computer image space on a patient's preoperative or Intraoperative 2D or 3D image data. || The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

ExacTrac Version 6.0.4; Model/Catalog Numbers: 1) 20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE;  2) 20834C EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE;  3) 20835C EXACTRAC 6.0 IR MONITORING SOFTWARE;  4) 20853C EXACTRAC 6.0 X-RAY LIMITED SOFTWARE;  5) 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR);  6) 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR);  7) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR);  8) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED;  9) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC;  10) 49936A ET SOFTWARE UPDATE 6.0.X TO 6.0.4;  11) 49938 ET SOFTWARE UPDATE 6.0.3TO 6.0.4;  12) 49939 ET SOFTWARE UPDATE 6.0.X to 6.0.4 P&R;  13) 49973B ET DATA PREP / REVIEW SYSTEM;  14) 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY;  15) 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED;  16) 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT

Radiology Devices

2

No

Worldwide Distribution - USA including CA, CT, and IL; Internationally to France, Germany, Japan, Netherlands, Russia, and Slovenia.

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 to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.

Model/Catalog Numbers: 25100-05 PATIENT DATA MANAGER 2.0.11 25100-06 PATIENT DATA MANAGER 2.0.2.   Software Versions: 2.0.0, 2.0.1, and 2.0.2

Radiology Devices

2

No

Worldwide Distribution-USA (nationwide) including the states of AL, AK, AZ, CA, FL, GA, IA, IL, KS, MD, MO, MS, NC, NY, OH, PA, SD, TX, VA, VT, WA, and WI, and the countries of Australia, Austria, Belgium, Brazil, Chile, China, Ecuador, France, Germany, Japan, Netherlands, New Zealand, Norway, Qatar, Russia, Spain, Switzerland, Taiwan, United Arab Emirates, and United Kingdom.

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. The software can transfer images to and from picture archiving and communication systems (PACS), file servers, or removable storage media.

ExacTrac version v.6.0.3.

Radiology Devices

2

No

Worldwide Distribution -- USA, including the states of CA, IN, LA, MA, OH, TX, and WI, and the countries of Australia, China, France, Germany, Japan, Netherlands, and the United Kingdom.

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.X TO 6.0 (IR+XR) || 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC || 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR) || 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR) || 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED || 49973B ET DATA PREP / REVIEW SYSTEM || 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT || 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY || 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED

Catalog Number: 22264; Serial Numbers: 000000000038012001 , 000000000060912001 , 000000000189912001 , 000000000224912001 , 000000000235512001 , 000000000282912001 , 000000000313612001 , 000000000319412001 , 000000000351112001 , 000000000356912001 , 000000000367212001 , 000000000433712001 , 000000000482012001 , 000000000502812001 , 000000000645612001 , 000000000731112001 , 000000000837312001 , 000000000898312001 , 000000000956812001 , 000000000998412001 , 000000001012812001 , 000000001105412001 , 000000001231812001 , 000000001353512001 , 000000001355412001 , 000000001433712001 , 000000001473712001 , 000000001493512001 , 000000001493712001 , 000000001566212001 , 000000001579112001 , 000000001635112001 , 000000001758212001 , 000000001770212001 , 000000001789312001 , 000000001868312001 , 000000001895412001 , 000000001909912001 , 000000002036112001 , 000000002309812001 , 000000002439112001 , 000000002468312001 , 000000002503012001 , 000000002573012001 , 000000002682913001 , 000000003000913001 , 000000003053313001 , 000000003066813001 , 000000003071613001 , 000000003087613001 , 000000003109513001 , 000000003109613001 , 000000003230113001 , 000000003246713001 , 000000003304113001 , 000000003331913001 , 000000003379313001 , 000000003453413001 , 000000003453513001 , 000000003622213001 , 000000003671813001 , 000000003744413001 , 000000003758413001 , 000000003819613001 , 000000003824913001 , 000000003866013001 , 000000003937813001 , 000000004094013001 , 000000004147413001 , 000000004356413001 , 000000004404013001 , 000000004489313001 , 000000004489413001 , 000000004505313001 , 000000004821913001 , 000000004882013001 , 000000004905013001 , 000000005396313001 , 000000005407413001 , 000000005505113001 , 000000005506013001 , 000000005531913001 , 000000005552313001 , 000000005578713001 , 000000005659713001 , 000000005702513001 , 000000005788213001 , 000000005817113001 , 000000005904513001 , 000000005904613001 , 000000005904713001 , 000000005904813001 , 000000005946713001 , 000000006046413001 , 000000006046513001 , 000000006096913001 , 000000006136313001 , 000000006233113001 , 000000006296713001 , 000000006426913001 , 000000006427213001 , 000000006621613001 , 000000006621613002 , 000000006656613001 , 000000006792613001 , 000000006833413001 , 000000006839413001 , 000000006998813001 , 000000007000113001 , 000000007122113001 , 000000007172913001 , 000000007405013001 , 000000007588513001 , 000000007637114001 , 000000007679714001 , 000000007698714001 , 000000007784614001 , 000000007859414001 , 000000007906314001 , 000000008020214001 , 000000008031314001 , 000000008184514001 , 000000008193214001 , 000000008199814001 , 000000008214014001 , 000000008259514001 , 000000008383314001 , 000000009718312001 , 000000009720812001 , 000000009781112001 , 000000009802512001 , 000000009901612001 , 000000009983912001

Neurological Devices

2

No

Worldwide Distribution - US Distribution including the states of AZ, CA,GA, IL, IN, LA, MA, MI, NY, NC, OH, PA, TN, TX and WI and the countries of Australia, Austria, Belgium, Brazil, Chile, Czech Republic, France, Germany, Italy, Japan, Malaysia, Netherlands, Norway, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom.

Brainlab, Spine & Trauma 3D 2.0, Navigation Software. An intraoperative image-guided localization system to enable minimally invasive surgery. Catalog Number: 22264