Brainlab AG

bundle #06-69448-49700, tilt module #3520-05-011-49720; bundle #06-69445-49700, tilt module #3520-05-006-49720; bundle #06-78573-49700, tilt module #3520-05-017-49720; bundle #06-69573-49700, tilt module #3520-05-002-49720; bundle #06-78149-49700, tilt module #3520-05-015-49720; bundle #06-66427-49700, tilt module #3520-05-013-49720; bundle #06-62416-49700, tilt module #3520-05-008-49720;  tilt module #3520-05-018-49720;  bundle #06-77290-49700, tilt module #3520-05-019-49720; bundle #06-77669-49700, tilt module #3520-05-020-49720; bundle #06-78440-49700, tilt module #3520-05-014-49720; bundle #06-74601-49700, tilt module #3520-05-010-49720; bundle #06-64377-49700, tilt module #7520-05-005-49720;

Radiology Devices

2

No

Nationwide, including the states of California, Colorado, Florida, Illinois, Maryland, Michigan, Missouri, New Hampshire, New York, North Carolina, Ohio, Pennsylvania, Tennessee and Texas

ExacTrac Robotics, sold alone as Robotic Tilt Module catalog 49720 and in a bundle as catalog 49700, for installation on the Varian Exact Couch, a component of the Novalis Shaped Beam Surgery System; a table tilt device - powered radiation therapy patient support assembly; BrainLab AG, Ammerthalstrasse 8, 85551 Heimstetten, Germany

All versions of BrainSCAN or iPlan RT Dose software used with BrainLAB conical collimators.

Radiology Devices

2

No

Nationwide.

BrainLab Radiotherapy Treatment Planning Software; || Catalog number 20610 - Radiosurgery 3.0 || Catalog number 20620 - Radiosurgery 3.5 and || Catalog number 20630 - Circular ARC SRS/SRT Planning. || The software is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck, and extracranial lesions. It is intended to be used by experienced and trained health professionals.

Catalog/version number 40700-3A, all serial numbers

Radiology Devices

1

No

Ohio, Washington and France

BrainLAB Target Positioner for Leksell Headring used with the iPlan RT Dose (versions 3.0, 3.0.1 and 3.0.2) and BrainSCAN (version 5.31) Radiotherapy Treatment Planning Software, ; BrainLab AG, Ammerthalstrasse 8, 85551 Heimstetten, Germany; catalog/version number 40700-3A

VVsky Art. No. 50945; all VVsky products with Data Billboards and/or microscope integrations and/or Device Connections Panels (Wall Panels)

Radiology Devices

2

No

Nationwide Distribution --- including states of Arizona, Connecticut t, Idaho, Massachusetts, Michigan, Minnesota, New York, Ohio, Pennsylvania, Texas, Virginia and Wisconsin.

VectorVision (VV) Sky Navigation Platform (19" Computer Rack); the 19" computer rack is a component of the VVsky Vario, BrainSUITE iMRI, BrainSUITE NET and BrainSUITE iCT systems; BrainLab AG, Kapellenstrasse 12, 85622 Feldkirchen, Germany || Intended to be an intraoperative image guided localization system to enable minimally invasive surgery. Indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified to relative to a CT, CTA, X-ray, MR, MRA and ultrasound based model of the anatomy.

Model 41600; Serial Numbers: 02-027-41600, 02-025-41600, 01-012-41600, 41600-093-00, 41600-001, 01-039-41600, 01-043-41600, 01-004-41600, 01-007-41600, 01-019-41600, 02-040-41600, 01-036-41600 and 02-008-41600.

Radiology Devices

2

No

Nationwide Distribution - AL, CA, CO, FL, GA, IL, KS, KY, LA, MD, MI, MN, MS, ME, NJ, NY, OR, TN, TX, UT, VA, WV, WA and WI.

BrainLab Micro-Multileaf-Collimator, model 41600; BrainLab AG, Kapellenstrasse 12, 85622 Feldkirchen, Germany. || The mMLC is intended to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from access radiation.