Allura Xper

  • 모델명 / 제조번호(시리얼번호)
    Serial numbers affected:  17, 21, 22, 39, 44, 48, 49, 52, 54, 60, 81, 83, 93, 107, 111, 118, 121, 122, 135, 141, 144, 145, 153, 159, 160, 163, 165, 166, 167, 168, 170, 175, 176, 178, 179, 183, 184, 186, 187, 190, 191, 195, 196, 202, 203, 207, 211, 212, 213, 214, 220, 222, 225, 230, 231, 232, 234, 239, 246, 248, 249, 250, 251, 252, 254, 255, 262, 263, 265, 269, 270, 272, 277, 278, 283, 285, 286, 287, 289, 294, 301, 302, 303, 304, 306, 308, 310, 314, 315, 318, 321, 326, 327, 332, 337, 340, 341, 343, 347, 361, 362, 366, 369, 376, 379, 384, 387, 388, 389, 396, 404, 423, 425, 426, 435, 439, 445, 458, 467, 468, 469, 470, 471, 472, 479, 490, 494, 498, 504, 512, 514, 515, 518, 520, 521, 523, 528, 532, 534, 535, 543, 545, 553, 554, 559, 560, 579, 582, 586, 587, 588, 591, 592, 593, 595, 596, 599, 601, 602, 604, 606, 609, 611, 612, 615, 616, 618, 622, 623, 625, 626, 627, 628, 632, 634, 637, 638, 641, 642, 647, 649, 651, 654, 655, 658, 661, 663, 664, 667, 668, 670, 671, 672, 673, 674, 675, 676, 677, 678, 679, 680, 681, 683, 685, 686, 689, 691, 692, 694, 700, 701, 702, 705, 706, 707, 709, 716, 718, 722, 723, 730, 731, 737, 738, 741, 742, 744, 746, 750, 751, 752, 753, 754, 759, 765, 766, 770, 771, 773, 774, 775, 776, 777, 778, 779, 780, 781, 782, 785, 786, 788, 789, 790, 796, 797, 800, 804, 806, 808, 810, 813, 816, 821, 822, 823, 825, 826, 827, 828, 829, 830, 840, 841, 842, 843, 844, 845, 847, 848, 849, 850, 851, 852, 853, 857, 860, 861, 862, 863, 878, 882, 882, 886, 888, 892, 893, 894, 895, 896, 903, 904, 905, 906, 907, 908, 910, 911, 912, 913, 914, 919, 920, 921, 923, 924, 927, 929, 930, 933, 934, 939, 942, 943, 953, 959, 960, 961, 962, 966, 968, 970, 971, 972, 976, 984, 991, 992, 993, 994, 1007, 1009, 1015, 1032, 1038, 1044, 1045, 1046, 1056, 1075, 1076, 1081, 1085, 1090, 1092, 1093, 1095, 1096, 1098, 1103, 1104, 1105, 1107, 1108, 1114, 1115, 1116, 1118, 1119, 1124, 1126, 1127, 1128, 1132, 1138, 1139, 1140, 1141, 1145, 1147, 1150, 1153, 1161, 1166, 1167, 1168, 1169, 1170, 1174, 1176, 1177, 1178, 1179, 1183, 1187, 1188, 1189, 1190, 1195, 1196, 1201, 1202, 1205, 1206, 1207, 1209, 1211, 1221, 1223, 1227, 1228, 1229, 1235, 1236, 1237, 1240, 1241, 1242, 1252, 1253, 1256, 1258, 1259, 1267, 1268, 1269, 1273, 1274, 1276, 1277, 1279, 1291, 1293, 1294, 1297, 1298, 1300, 1302, 1318, 1321, 1326, 1331, 1338, 1364, 1374, 18165, 43041, 43048, 43051, 43057, 43068, 43070, 43076, 43080, 43081, 43090, 43093, 1674122, 521, 9A, and CG22N41.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    Allura Xper FD20 X-Ray System, Release 2.2, Philips Medical Systems, Bothell, WA 98021
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 334 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    7220063, 722064, 22065, 722066, 722078, 722079
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) Distribution.
  • 제품 설명
    Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 || The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures ( such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP) Non-vascular interventions such as drainages, biopsies and vertebroplastics procedures The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    All Allura Xper FD and and Xper FD ORT manufactured from July 2003 - May 2017 with system Codes: 722001  722002  722003 722010 722026 722005 722011 722027 722006 722012 722028 722008 722013  722015 722023 722035 722020  722029  722038  722039  722058  722059
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide
  • 제품 설명
    Allura Xper FD and and Xper FD ORT - Philips X-ray Systems || Product Usage: || The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP). The Allura Xper FD20, Allura Xper FD20/10, Allura Xper FD20/15 and Allura Xper FD10/10 is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations and ElectroPhysiology. Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: The Allura Xper FD series is compatible with a hybrid Operating Room (OR Table)
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Allura Xper systems - Model #'s 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 722059, 722063, 722064, 722065, 722066, 722078, 722079, (added as of 6/25/2018) 1120
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide; foreign distribution to Brazil, Germany, Iceland, Japan, Mexico, and (updated 6/25/18) Saudi Arabia.
  • 제품 설명
    Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. || Product Usage: || The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implanatations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Product name: Allura Xper R8.1 .25.0  Allura Xper R8.1 .25.1 Allura Xper R8.1 .25.5 Allura Xper R8.2.25.0 Allura Xper R8.2.25.5 Allura Xper R8.2.27 UNIQ Ri .0.10 UNIQ Ri .0.10.5  Product code: 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 7322039, 722058, 722059.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The product was distributed to the following countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Cuba, Czech Republic, Denmark, Estonia, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Republic of Korea, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Caledonia, Norway, Pakistan, Poland, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, and United Kingdom.
  • 제품 설명
    Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system || Product Usage: || The Allura Xper ED series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, eg peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placement, embolization and thrombolysis. Cardiac imaging applications including diagnostics, interventional minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures. Additionally: The Allura Xper ED series is compatible with a hybrid operating room.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    N/A
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