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Sources: EU EUDAMED, US FDA
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SonoCine Image Acquisition Station
FDA UDI
SONOCINE, INC.·B3015017750001·SonoCiné Image Acquisition Station Model 201, P...
ACUSON and SONOLINE Antares and Antares PE ultrasound systems at product versions 4.0 and 5.0 with cardiovascular options installed; ACUSON Antares 4.0 & 5.0: 10032747, 10037592, 10040728; ACUSON Antares PE 4.0 & 5.0: 10032746, 10037591, 10038202, 10040729; SONOLINE Antares 4.0 & 5.0: 05936518, 08653771, 10037593; Antares Cardio Options: 10036613, 10036588, 10036585, 10436250; Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Business Unit Ultrasound, Mountain View, CA The ACUSON Antare is a general purpose Diagnostic Ultrasound system. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in: B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, Harmonic Imaging, or 3D/4D imaging on a FPD display. The Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc., Mountain View, CA
1230 Shorebird Way
P.O. Box 7393
Mountain View CA 94043·Product code IYN·August 17, 2010
Sonoline G50/G60 Ultrasound System, Software versions 1.0.0 to 1.5.0b. The product is a general purpose, mobile software controlled diagnostic ultrasound system.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code IYN·August 5, 2008