GE OEC Medical Systems,Inc

Part Number: GE 1005556.

Radiology Devices

2

No

AL, CO, CA, FL, GA, LA, IL, IN, MA, MD, MI, MS, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, WV, including one VA facility in TN. No military or foreign distribution.

Spine Clamp, an accessory to the InstaTrak 3500 Plus system. Clamp is attached to the spine to provide a mounting point for a transmitter.

All MiniView 6800 systems.

Radiology Devices

2

No

Nationwide.

MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system.

Catalog Number 1004070. Serial numbers: 82-2771-N, 822920-N, 82-2921-N, 82-3012-N, 82-3188-N, 82-3189-N, 82-3289-N, 89-2453-N, 89-2509-N, 89-2524-N, 89-2529-N, 89-2742-N, 89-2743-N, 89-3121-N, 89-3122-N, 89-3123-N, 8S-2094-N, 8S-2150-N, 8S2151-N, 8S-2177-N, 8S-2178-N, 8S-2179-N, 8S-2223-N, 8S-2224-N, 8S-2225-N, 8S-2226-N, 8S-2244-N, 8S-2261-N, 8S-2262-N, 8S-2292-N, 8S-2336-N, 8S-2337-N, 8S-2338-N, 8S-2339-N, 8S-2340-N, 8S-2341-N, 8S-2376-N, 8S-2380-N, 8S-2386-N, 8S-2390-N, 8S-2394-N, 8S-2443-N, 8S-2444-N, 8S-2445-N, 8S-2515-N, 8S-2516-N, 8S-2524-N, 8S-2549-N, 8S-2589-N, 8S-2590-N, 8S-2591-N, IT25147P, IT25169P, IT35153P, IT35184P, IT35191P, IT35197P, IT35198P, IT35207P, IT35208P, IT35209P, IT35211P, IT35214P, IT35216P, IT35221P, IT35223P, IT35225P, IT35226P, IT35228P, IT35232P, IT35234P, IT35240P, IT35242P, IT35244P, IT35245P, IT35250P, IT35255P, IT35260P, IT35262P, IT35263P, IT35267P, IT35269P, IT35272P, IT35275P, IT35280P, IT35285P, IT35287P, IT35291P, IT35292P, IT35293P, IT35294P, IT35295P, IT35296P, IT35299P, IT35301P, IT35302P, IT35304P, IT35305P, IT35312P, IT35315P, IT35316P, IT35317P, IT35323P, IT35324P, IT35327P, IT35328P, IT35330P, IT35336P, IT35339P, IT35342P, IT35344P, IT35348P, IT35361P, IT 35370P, IT35375P, IT35379P, IT35381P, IT35383P.

Radiology Devices

2

No

AL, AZ, CA, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NJ, NV, NY, OR, PA, SC, TN, TX, UT, VA, WI, WV and one military facility in DC. Foreign distribution to Canada, Denmark, France Germany, Hong Kong, Italy, Japan, Switzerland, UK.

GE Healthcare Navigation Pin Transmitter (GE P/N 1004070) -Medical Systems InstaTrak Pin Transmitter

Axcess System Kit P/N: 1005869-001

Radiology Devices

2

No

Domestic distribution: VA, CT, KY, NJ, LA, PA, TN, OK, CA. Foreign distribution to Germany. There were no military or VA facilities.

InstaTrak 3500 Plus Navigation and Visualization System

InstaTrak 3500 Plus systems with version 5.1 software.   The accessory involved: Shunt Guide (P/N 1004362) when used with version 5.1 software.

Radiology Devices

2

No

Worldwide distribution --- USA including states of AK, AZ, AL, CA, CT, IA, IL, MD, ME, MO, MT, MS, NC, NJ, NY, OH, PA, RI, SD, UT, TX, VA, WA and WI and countries of France, United Kingdom, Japan, Italy, India and Canada

InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body)