MX8000 IDT CT SYSTEM

  • 모델명 / 제조번호(시리얼번호)
    Computed Tomography (CT) Model #455011202691, Serial Number: 5754, 6437, 6467, 6543, 6835, 7253, 7576, 7579, 7639, 8756, 8757, 10102, 10103, 10108, 10109, 10111-10114, 10116, 10117, 10119, 10120, 10122-10126, 10128, 10129, 10132, 10134-10144, 10146, 10151, 10154, 10158, 10161, 10163, 10167, 10173, 10174, 10175, 10179-10184, 10195, 10322, 10356, 10361, 10427, 10437, 10449, 10456, 10484, 10492, 10537, 10598, 10604, 10668, 10690, 10722, 10745, 10770, 10778, 10821, 10822, 10841, 10889, 10906, 10938, 10939, 10940, 10943, 10945, 10952, 10965, 10998, 11025, 11037, 11054, 11065, 11085, 11089, 11099, 11102, 11103, 11104, 11113, 11121, 11127, 11140, 11148, 11149, 11151, 11152, 11168, 11169, 11174, 11229, 11230, 11232, 11260, 11274, 11280, 11282, 11291, 11314, 11339, 11341, 11557, 11564, 11577, 11585, 11610, 11620, 11630, 11631, 11633, 11663, 11667, 11668, 11708, 11742, 11744, 11745, 11751, 11752, 11754, 11758, 11766, 11780, 11783, 11787, 11790, 11792, 11795, 11797, 11803, 11804, 11807, 11809, 11810, 11812, 11813, 11832, 11834, 11838, 11839, 11841, 11844, 11846, 11848, 11850, 11852, 11853, 11854, 11855, 11858, 11859, 11862, 11863, 11864, 11865, 11870, 11872, 11877, 11879, 11884, 11886, 11888, 11892, 11897, 11921, 11922, 11928, 11937, 11981-12064, 12071, 12073-12099, 12105, 12109, 12138, 12139, 12140, 12144, 12146, 12149, 12152, 12156, 12164, 12166, 12168, 12179, 12201, 12203, 12250-12259, 12272, 12276-12299, and 12450-12453.  Nuclear Medicine (NM) Model #455011002031, Serial Number: 4123, 7003, 7004, 7005, 7013, 7016, 7052, 7061, 7066, 7145, 7060, 7050, 7011, and 7020.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US including DC (states of AL, AR, AZ, CO, DC, FL, IL, KY, LA, MA. ME, MI, MN, MO, NJ, NY, OH, OR, PA, SC, TN, TX, VT, and WI) and countries of Africa, Albania, Austria, Australia, Bangladesh, Belgium, Brazil, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Holland, India, Iraq, Israel, Italy, Japan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Puerto Rico, Russia, Singapore, Spain, South Africa, Sweden, Switzerland, Syria, Tahiti, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Venezuela.
  • 제품 설명
    Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1. Model #455011202691 for Computed Tomography (CT); Model #455011002031 for Nuclear Medicine (NM). || The "Extended Brilliance Workspace (EBW)" Dental Application v4.0 and v4.0.1 is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
  • Source
    USFDA