ACUSON X300, X300 PE and SONOVISTA X300

  • Modèle / numéro de série
    All units of these models.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide)and the countries of Antares distribution includes: United Arab Emirates-AE, Austria-AT, Australia-AU, Azerbaijan-AZ, Brazil-BR, Belarus-BY, Canada-CA, Switzerland-CH, Chile-CL, China-CN, Czech Republic-CZ, Germany-DE, Denmark-DK, Egypt-EG, Spain-ES, France-FR, Great Britain-GB, Guatemala-GT, Croatia-HR, Hungary-HU, Indonesia-ID, Ireland-IE, India-IN, Italy-IT, Jordan-JO, Japan-JP, South Korea-KR, Moldova-MD, Mexico-MX, Malaysia-MY, Netherlands NL, Norway-NO, New Zealand-NZ, Poland-PL, Portugal-PT, Romania-RO, Serbia-RS, Russian Federation-RU, Saudi Arabia-SA, Sweden-SE, Singapore-SG, Slovak Republic-SK, Suriname-SR, Turkey-TR, Taiwan-TW, Ukraine-UA, United States-US, Uruguay-UY, Uzbekistan-UZ, Venezuela-VE, Vietnam-VN, South Africa-ZA S2000 distribution includes: Austria-AT, Australia-AU, Brazil-BR, Canada-CA, Switzerland-CH, Chile-CL, China-CN, Czech Republic-CZ, Germany-DE, Denmark-DK, Spain-ES, Finland-FI, France-FR, Great Britain-GB, Hong Kong-HK, Indonesia-ID, India-IN, Italy-IT, Japan-JP, South Korea-KR, Kazakhstan-KZ, Lebanon-LB, Mexico-MX, Norway-NO, Philippines-PH, Poland-PL, Portugal-PT, Romania-RO, Russian Federation-RU, Sweden-SE, Slovak Republic-SK, Turkmenistan-TM, Turkey-TR, Taiwan-TW, United States-US X300 distribution includes: AE (United Arab Emirates) , AL (Albania) , AN (Netherlands Antilles), AO (Angola), AR (Argentina), AT (Austria), AU (Australia), AZ (Azerbaijan), BA (Bosnia-Herzegovina), BD (Bangladesh), BE (Belgium), BG (Bulgaria), BN (Brunei), BO (Bolivia), BR (Brazil), BY (Belarus), CA (Canada), CH (Switzerland), CL (Chile), CN (China), CO (Colombia), CV (Cape Verde), CZ (Czech Republic), DE (Germany), DK (Denmark), DZ (Algeria), EC (Ecuador), EG (Egypt), ES (Spain), ET (Ethiopia), FJ (Fiji), FR (France), GB (United Kingdom), GE (Georgia), GR (Greece), HK (Hong Kong), HN (Honduras), HR (Croatia), HU (Hungary), ID (Indonesia), IE (Ireland), IN (India), IR (Iran), IT (Italy), JO (Jordan), JP (Japan), KE (Kenya), KR (Korea, South), KW (Kuwait), KZ (Kazakhstan), LT (Lithuania), LV (Latvia), LY (Libya), MD (Moldova), ME (Montenegro), MK (Macedonia), MM (Myanmar), MU (Mauritius), MX (Mexico), MY (Malaysia), NG (Nigeria), NI (Nicaragua), NL (Netherlands), NO (Norway), NP (Nepal), NZ (New Zealand), PE (Per¿), PH (Philippines), PK (Pakistan), PL (Poland), PS (Palestine), PT (Portugal), QA (Qatar), RS (Serbia), RO (Romania), RU (Russia), RW (Rwanda), SA (Saudi Arabia), SC (Seychelles), SE (Sweden), SG (Singapore), SI (Slovenia), SK (Slovakia), SV (El Salvador), SY (Syria), TH (Thailand), TM (Turkmenistan), TN (Tunisia), TR (Turkey), TT (Trinidad/Tobago), TW (Taiwan, ROC), UA (Ukraine), US (United States of America), UY (Uruguay), UZ (Uzbekistan), VE (Venezuela), VN (Viet Nam), YE (Yemen), ZA and (South Africa)
  • Description du dispositif
    ACUSON X300, X300 PE and SONOVISTA X300 (all versions) with cardiovascular options installed; || ACUSON X300: 10037409, 10132987, 10038837; || SONOVISTA X300: 10133170; || ACUSON X300 PE: 10348531, 10348532, 10348533; || X300 Cardiovascular Options: 10133037, 10348777, 10349032, 10427797, 10427822, 10427816, 10563788; || Product is manufactured and distributed by || Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA || The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Siemens Medical Solutions USA, Inc., Mountain View, CA, 1230 Shorebird Way, P.O. Box 7393, Mountain View CA 94043
  • Société-mère du fabricant (2017)
  • Source
    USFDA