Toshiba American Medical Systems Inc

Lot numbers not utilized. Serial Numbers:A5B1192003 A5B1192004, A5B11Y2005, A5B11Z2007, A5C1212008, A5C1212009, A5C1222010, A5C1232011, A5C1252012, A5C1262013, A5C1282014, A5C1292015, A5C12X2016, A5C12Y2017, A5C12Z2018, A5D1312019, A5D1322020, A5D1362021, XIB-A5A1082001, XIB-A5B11Y2006, A5D1372022, A5B1182002.

Radiology Devices

2

No

USA Nationwide Distribution in the states of: CA, FL, GA, IA, NV, NY, LA, IN, PA, OR, TX, and WI.

Titan 3T MRI System, MRT-3010A/5. || Product Usage: Usage: || MRI system.

Product Numbers: MRT-1504/A4, MRT-1504/S4, MRT-3010/A5, MZKT-UPKHE/S1. Serial Numbers unique to each consignee.

Radiology Devices

2

No

USA Nationwide Distribution including the states of : IL, NH, MA, MI, MO, PR, NV, NM, MN, ID, NY, OH, NC, AZ, MS, LA, OR, PA, CA, and CT.

MRT-1504/A4 - Titan X MRI System || MRT-30 I0A/5 - Titan 3T MRI System || Product Usage: MRI System.

Serial Numbers: 1DA0962006, 1DA0972007, 2DA0792002, 2DA0792004, 2DA07X2005, 2DA07X2008, 2DA07Y2010, 2DA0842023, 2DA0842026, 2DA0862034, 2DA0862036, 2DA0872038, 2DA0882048, 2DA0882049, 2DA0882051, 2DA0882052, 2DA0882053, 2DA08X2061, 2DA08X2063, 2DA08X2067, 2DA08X2070, 2DA08X2071, 2DA08X2072, 2DA08Y2077, 2DA08Y2080, 2DA08Z2092, 2DA0952115, and 2DA0962116

Radiology Devices

2

No

Nationwide: AL AR AZ CA CO FL GA IA MA MD ND NJ NV NY OH PA PR andVA

Aquilion One Whole Body X-Ray CT Scanner || Whole body computed tomography scanning

Serial Number: 2DA0882051

Radiology Devices

2

No

Nationwide distribution: USA including states of: AL, AR, CA, CO, FL, GA, KY, MA, MD, MT, ND, NJ, NV, NY, OH, PA and Puerto Rico.

Whole Body X--ray Scanner || This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.

Item CFA Software Serial Number: Description TSX-301C/2D 2BA1362093 Aquilion One Vision

Radiology Devices

2

No

US Nationwide Distribution to CA, MA, MD

Cardiac Function Analysis Software || Product Data No. MPDCT0301EAD || CSCF-003A || The software is applicable to the following CT systems: || Aquilion ONE TSX-301C || X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, station, gantry and patient couch operation controls, image reconstruction, high-speed volume scan, high-quality images, selectable image slice thickness, dual-monitor system, improved image diagnosis functions, high-speed volume data workflow, exposure reduction, ECG-gated scan and reconstruction, and SUREFluoro. || The CT cardiac function analysis software is used to analyze cardiac function using data obtained by performing cardiac MPR processing for ECG-gated scan data according to the cardiac axis. Aquilion ONE is a dynamic volume CT system that supports whole-body scanning. This 320-detector row system generates 640 slices per rotation using the coneXact reconstruction algorithm. In addition, the high-speed rotation mechanism and the fast reconstruction unit of the system allow the rapid image acquisition to further improve throughput in CT examinations.