Toshiba American Medical Systems Inc

Item CFA Software Serial Number: Description TSX-301A/2D 1BA07X2002 Aquilion One TSX-301A/2D 1BA07X2001 Aquilion One

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-301A/2D || 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.

Serial No. U7E1462009, ACA1472001, UEB1352004, UFD1442017, AAA1492001, ACA1492002, ULD1412014, AHA1482001, UPB1372006, ULD1392013, U6A1472001, ULD1452016, UPB1352005, ULD1452015, UDE1352017, A4B1472002, U4A14X2001, UPB1342004, 99B1342133, 99B1342134, UFD1452018, UFD13X2015, UFD13X2016, UFD1362014, UUC1452012, A6A1492002, UUC13Z2011, AAA14X2002, A4A13Z2001.

Radiology Devices

2

No

Nationwide Distribution

INFX-8000V Interventional Angiography System. CAT-880B catheterization table. || Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.

DREX-KL80  NO. SERIAL# LAST FOUR . MANUFACTURE DATE 1 99C1042292 2292 APRIL 2010 2 99C1162353 2353 JUNE 2011 3 99C1062307 2307 JUNE 2010 4 99C1072311 2311 JULY 2010 5 99C0972246 2246 JULY 2009 6 99C09Z2273 2273 DECEMBER 2009 7 99C1212372 2372 JANUARY 2012 8 99C0932234 2234 MARCH 2009 9 99C09X2262 2262 OCTOBER 2009 10 99C1182359 2359 AUGUST 2011 11 99C1022285 2285 FEBRUARY 2010 12 99C10Y2329 2329 NOVEMBER 2010 13 99C1092316 2316 SEPTEMBER 2010 14 99C1262385 2385 JUNE 2012 15 99C09Y2265 2265 NOVEMBER 2009 16 99C1122344 2344 FEBRUARY 2011 17 99C0982248 2248 AUGUST 2009 18 99C09Z2276 2276 DECEMBER 2009 19 99C1282389 2389 AUGUST 2012 20 99C1072309 2309 JULY 2010 21 99C0912228 2228 JANUARY 2009 22 99C1062303 2303 JUNE 2010 23 99C1212374 2374 JANUARY 2012 24 99C11Y2369 2369 NOVEMBER 2011 25 99C09X2260 2260 OCTOBER 2009 26 99C1042297 2297 APRIL2010 27 Jll1293530 3530 SEPTEMBER 2012 28 99C1012278 2278 JANUARY 2010 29 99C10Y2328 2328 NOVEMBER 2010 30 99C1052299 2299 MAY 2010 31 99C0982250 2250 AUGUST 2008 32 99C1242381 2381 APRIL 2012 33 J1H08Z3448 3448 DECEMBER 2008 34 99C1252383 2383 MAY 2012 35 99C1022287 2287 FEBRUARY 2010 36 99C1072308 2308 JULY 2010 37 99C1042291 2291 APRIL2010 38 99C1042290 2290 APRIL2010 39 99C09X2258 2258 OCTOBER 2009 40 99B0892210 2210 SEPTEMBER 2008 41 99C1162355 2355 JUNE 2011 42 99C11X2364 2364 OCTOBER 2011 43 99C1162352 2352 JUNE 2011 44 99B08Y2216 2216 NOVEMBER 2008 45 99C11X2367 2367 OCTOBER 2011 46 99C12Y2396 2396 NOVEMBER 2012 47 99C1162354 2354 JUNE 2011 48 99C1012282 2282 JANUARY 2010 49 99C1042294 2294 APRIL 2010 50 99C0912227 2227 JANUARY 2009 51 99C12X2393 2393 OCTOBER 2012 52 99C0982251 2251 AUGUST2009 53 99C1182358 2358 AUGUST2011 54 99B08X2213 2213 OCTOBER 2008 55 99C1012279 2279 JANUARY 2010 NO. SERIAL# LAST FOUR MANUFACTURE DATE 56 99C1062305 2305 JUNE 2010 57 99D0962239 2239 JUNE 2009 58 99C0922230 2230 FEBRUARY 2009 59 99C0992255 2255 SEPTEMBER 2009 60 99C09Z2271 2271 DECEMBER 2009 61 99C1092317 2317 SEPTEMBER 2010 62 99C1212371 2371 JANUARY 2012 63 99C1052302 2302 MAY2010 64 99C1012284 2284 JANUARY 2010 65 99C1152349 2349 MAY2011 66 99C1082315 2315 AUGUST2010 67 99C10Y2327 2327 NOVEMBER 2010 68 99C1272387 2387 JULY 2012 69 99C0972243 2243 JULY 2009 70 99C1062304 2304 JUNE 2010 71 99C10X2324 2324 OCTOBER 2010 72 99C09X2263 2263 OCTOBER 2009 73 99C0992256 2256 SEPTEMBER 2009 74 J1109X3472 3472 OCTOBER 2009 75 99C09X2261 2261 OCTOBER 2009 76 99B08Y2219 2219 NOVEMBER 2008 77 99B08X2214 2214 OCTOBER 2008 78 99C09Y2268 2268 NOVEMBER 2009 79 99C1132346 2346 MARCH 2011 80 99C1012281 2281 OCTOBER 2010 81 99C1122341 2341 FEBRUARY 2011 82 99C1122342 2342 FEBRUARY 2011 83 99C12X2394 2394 OCTOBER 2012 84 99C12X2392 2392 OCTOBER 2012 85 99C0962241 2241 JUNE 2009 86 99C11X2365 2365 OCTOBER 2011 87 99C0952238 2238 MAY2009 88 99C0992257 2257 SEPTEMBER 2009 89 99C1152350 2350 MAY2011 90 J1H0973467 33467 JULY 2009 91 99C1012277 2277 JANUARY 2010 92 99C09Y2264 2264 NOVEMBER 2009 93 99C10Z2337 2337 DECEMBER 2010 94 J1H0953463 3463 MAY 2009 95 99B08Y2217 2217 NOVEMBER 2008 96 99C1222376 2376 FEBRUARY 2012 97 99C10X2325 2325 SEPTEMBER 2010 98 99C1032289 2289 MARCH 2010 99 J1109Y3476 3476 NOVEMBER 2009 100 99C1052300 2300 MAY 2010 101 99C1252384 2384 MAY 2012 102 99C1072312 2312 JULY 2010 203 99C1022286 2286 FEBRUARY 2010 104 99C0952237 2237 MAY 2009 105 99C0972245 2245 JULY 2009 106 99C10X2326 2326 OCTOBER 2010 107 99C1282388 2388 AUGUST 2012 108 99C1182360 2360 AUGUST 2011 109 99C08Z2221 2221 DECEMBER 2008 110 J111023482 3482 FBRUARY 2010 NO. SERIAL# . LASTFOUR .¿ MANUFACTURE DATE 111 99B08Y221S 221S NOVEMBER 2008 112 99C1092319 2319 SEPTEMBER 2010 113 99C1112340 2340 JANUARY 2011 114 99C093223S 223S MARCH 2009 115 99C0962240 2240 JUNE 2009 116 99B08X2211 2211 OCTOBER 2008 117 99C0922233 2233 FEBRUARY 2009 118 99C1092321 2321 SEPTEMBER 2010 119 99C0922229 2229 FEBRUARY 2009 120 99C11S23S1 23S1 MAY 2011 121 J1H08X3442 3442 OCTOBER 2008 122 99C1072310 2310 JULY 2010 123 99B08Y2218 2218 NOVEMBER 2008 124 99C11623S6 23S6 JUNE 2011 125 99C09Y2266 2266 NOVEMBER 2009 126 99C1142348 2348 APRIL 2011 127 J1110X3S04 3S04 OCTOBER 2010 128 Jli12S3S29 3S29 MAY2012 129 99C08Z2222 2222 DECEMBER 2008 130 99C0972242 2242 JULY 2009 131 99C091222S 222S SEPTEMBER 2012 132 99C09Y2267 2267 NOVEMBER 2009 133 99C0972247 2247 JULY 2009 134 99B08X2212 2212 OCTOBER 2008 135 99C1112339 2339 JANUARY 2011 136 99C1072313 2313 JULY 2010 137 99C09922S4 22S4 SEPTEMBER 2009 138 99C1092320 2320 SEPTEMBER 2010 139 99C0972244 2244 JULY 2009 140 99C10S2298 2298 MAY 2010 141 99C09Z2274 2274 DECEMBER 2009 142 99C104229S 229S APRIL2010 143 99C09Z2272 2272 DECEMBER 2009 144 99C11X2368 2368 OCTOBER 2011 145 99C1212373 2373 JANUARY 2012 146 99C10X2323 2323 OCTOBER 2010 147 99C1012283 2283 JANUARY 2010 148 99B0892209 2209 SEPTEMBER 2008 149 99C08Z2220 2220 DECEMBER 2008 150 99C08Z2223 2223 DECEMBER 2008 151 99C1142347 2347 APRIL 2011 152 99B0892207 2207 SEPTEMBER 2008 153 99C09Z227S 227S DECEMBER 2008

Radiology Devices

2

No

US Nationwide Distribution

TOSHIBA Kalare Diagnostic X-Ray System || K110785

Lot Numbers not utilized. Serial Numbers: LGA0792628 LGA0792564 LGA0792565 LGA0792531 LGA0792540 LGA0792541 LGA0792617 LGA0792554 LGA0792626 LGA0792627 LGA0792552 LGA0792616 LGA0792563 LGA0792553 LGA0792615 LGA0792551 LGA0792613

Radiology Devices

2

No

Nationwide Distribution including and US Territory Puerto Rico

Xario Diagnostic Ultrasound System SSA-660A || Used for routine diagnostic imaging

Lot Numbers not utilized. Serial Numbers: 99A07Y2151 99E0993437 99K1285044 99F1033857 99F1033858 99F1033859 99K11Z4906 99K11Z4907 99J1114445 99G1094194 99H10X4240 99E0973301 99G1074050 99G1074051 99G1074052 99E0973302 99J1114443 99G1084118 99D0892684 99K1184804 99D08Y2744 99K1285039 99K11Z4917 99E0963141 99E0963157 99E0963158 99E0963168 99D0892680 99D0892687 99D08Z2840 99D0953122 99E0973308 99E09X3463 99F09Z3684 99D08Z2829 99E0993408 99K1285041 99D0892692 99A07Y2109 99E0993414 99E0993415 99K1214940 99E0983369 99D0892688 99D0892689 99D0892691 99D0892693 99C0872552 99C0872568 99A07Y2097 99A07Y2098 99B07Z2248 99E0993436 99E0993445 99K1234985 99D0953125 99K1184805 99K1285046 99K12X5050 99K12X5051 99K12X5052 99K12X5053 99D0912881 99D08Y2762 99D0922958 99D0922959 99D0922960 99H10X4236 99K12Y5055 99K11Z4928 99F09Z3691 99C0872564 99F1043913 99K1244991 99A07Y2086 99E0973304 99G1053958 99J1134603 99E0983371 99A07Y2100 99B07Z2242 99B07Z2251 99F09Z3664 99D0943018 99E09X3467 99D08Y2759 99D08Y2760 99C0872551 99A07Y2089 99D0922957 99H10X4242 99D0953102 99A07Y2092 99A07Y2106 99A07Y2157 99B07Z2233 99B07Z2258 99C0882610 99C0882611 99D0943045 99D0943047 99E0983370 99F1013749 99F1033860 99F1043912 99G1053954 99G1053956 99K11Z4904 99K1285040 99A07Y2094 99H10X4237 99D08Z2826 99G1053962 99F09Z3663 99K11Z4905 99E09X3450 99C0872566 99A07Y2104 99F1013734 99B07Z2260 99A07Y2083 99D0953124 99D0892681 99J1114444 99E0993446 99J1124539 99J1134600 99A07Y2108 99K11Z4929 99A07Y2085 99F1043911 99E09X3462 99C0882619 99D08Y2747 99C0882607 99C0882608 99F1013743 99A07Y2091 99E0993447 99E0993448 99E0973310 99E0983362 99A07Y2159 99A07Y2158 99B07Z2252 99E09X3504 99J1144668 99J1124540 99J1134601 99G1053951 99H10X4239 99I10Z4387 99I10Z4388 99D0922954 99K1164753 99K1265026 99B07Z2249 99H10X4235 99K1194857 99K11X4876 99D0912880 99F1013735 99K11X4864 99G1084120 99G1084121 99G1094181 99G1094182 99G1094183 99K11Z4922 99G1053960 99F1013737 99E0983372 99E0983373 99F09Z3668 99G1064005 99D0943049 99K1285038 99D0892690 99E09X3461 99D0943048 99D0912884 99E0993416 99E09X3460 99G1094184 99A07Y2081 99K11X4870 99B0832365 99B07Z2261 99E09X3458 99E09X3459 99D08Z2838 99D0932997 99D0892682 99D0912879 99G1053961 99G1084117 99D0943020 99I10Z4389 99B0812292 99B0812293 99J1114447 99G1063999 99G1064001 99G1053953 99J1124538 99K12Y5056 99G1094191 99F09Z3685 99D0932999 99F09Z3688 99F09Z3662 99D0953100 99K11Z4916 99D0922953 99E0963177 99E0973303 99E0963169 99F09Z3667 99F09Z3689 99B07Z2243 99E09X3505 99B07Z2254 99E09X3497 99B07Z2259 99D0953126 99B0832368 99E0993434 99E0993435 99A07Y2082 99B0812294 99F09Z3690 99F09Z3660 99F09Z3661 99K12X5054 99H10X4241 99A07Y2090 99F09Z3687 99K1194858 99F09Z3686 99D0912887 99F1013756 99D0912894 99G1094193 99K1164755 99D0912885 99F09Z3669 99F09Z3670 99C0882620 99C0882614 99K1164754 99E09X3451 99I10Z4391 99B0812295 99C0872565 99G1074048 99K1184801 99C0872567 99E0993444 99D08Z2836 99D08Y2746 99D0912896 99A07Y2107 99B07Z2241 99D08Y2745 99A07Y2080 99D0892685 99J1144667 99B07Z2244 99B07Z2245 99B07Z2246 99J1134602 99K11X4872 99K11X4874 99K11X4875 99K11Y4885 99K11Y4886 99A07Y2084 99B07Z2253 99D0912897 99G1074047 99K1214944 99A07Y2102 99A07Y2155 99K11X4863 99K11Z4923 99K1285045 99D0943019 99D0933004 99D0912877 99E0963143 99K1275036 99F09Z3659 99K11Z4925 99E0993412 99A07Y2087 99E0993411 99E0993413 99E0973306 99E0973307 99D0932998 99D08Z2839 99J1124537 99D0953101 99J1144669 99A07Y2103 99B07Z2231 99A07Y2105 99A07Y2152 99C0872550 99C0882606 99D0912895 99F1033856 99E09X3495 99E09X3496 99F09Z3657 99J1124533 99K1214942 99D0892694 99D08Y2758 99D0922961 99E0993407 99D0953094 99J1114448 99E0973309 99A07Y2101 99K1244990 99E09X3465 99C0882618 99F1013750 99F1013755 99J1144650 99K1244993 99A07Y2156 99A07Y2099 99F1013736 99A07Y2093 99K11Z4919 99K11Z4920 99G1053957 99D08Z2837 99C0882617 99D0922962 99D0932995 99E0963176 99B0812291 99K1265027 99F1013744 99F1013745 99J1144648 99B0832366 99D0933003 99E0993410 99K11X4871 99I10Z4390 99K1184802 99K1184803 99B07Z2256 99B07Z2257 99B0812299 99E09X3507 99E09X3508 99E09X3509 99E09X3510 99B07Z2232 99E0963144 99D0912886 99G1084119 99B07Z2255 99K1285042 99C0872549 99F09Z3658 99D0953103 99D0932996 99K1164751 99F1013748 99J1144649 99D0953123 99C0882615 99C0882616 99E0963170 99E0963171 99E0963172 99E0963173 99F09Z3665 99F09Z3692 99F1013738 99F1013742 99E0963154 99E0983359 99F1043914 99F1043915 99F1013741 99E0983360 99E0983361 99F09Z3683 99D0922947 99K1214939 99H10X4233 99H10X4234 99K11Z4903 99K1275037 99K1234986 99K1234987 99K11Z4926 99B07Z2230 99D0892686 99B07Z2247 99K1244992 99F1013746 99F1013747 99E0993438 99E0993442 99K1194859 99K11Z4927 99D08Y2743 99E0983358 99C0882612 99C0882613 99E0993443 99E0973300 99G1094192 99D08Z2830 99F1013758 99E0963142 99K1214943 99K11Z4918 99B0812296 99B0812297 99B0812298 99D0922946 99E0963156 99D0943046 99H10X4238 99A07Y2095 99D08Z2827 99C0882609 99A07Y2096 99A07Y2153 99E09X3466 99K1275035 99F09Z3671 99J1144671 99F09Z3666 99D08Z2828 99G1064002 99G1064004 99E0993409 99E0963140 99E0963155 99F1013757 99E0963174 99E0963175 99E09X3464 99D0892683 99J1144670 99B07Z2240 99B07Z2234 99E09X3449 99K1285043 99E09X3473 99E09X3474 99E09X3475 99B0812300 99E09X3506 99B0832367 99B0832369 99C0872553 99D0912883 99A07Y2154 99J1134604 99J1144646 99J1144647 99A07Y2088 99D0922955 99K1244989 99G1053952 99K11Z4924

Radiology Devices

2

No

Nationwide Distribution including and US Territory Puerto Rico

Xario XG Diagnostic Ultrasound System SSA-680A || Used for routine diagnostic imaging