6 results
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62ms
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Sources: EU EUDAMED, US FDA
SOLITE WELLBEING USA INC.
FDA registration
SOLITE WELLBEING USA INC.·3 products·🇺🇸 United States
Auxiliary 2 MHz Continuous Wave (CW) transducer, model number 8251046, when used with ACUSON Sequoia ultrasound systems at SW revision 12.X. Manufactured by Siemens Medical Solutions USA, Inc., Ultrasound Business Unit, Mountain View, CA. The ACUSON Sequoia is a general purpose Diagnostic Ultrasound system. It is intended for the following applications: Abdominal, General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, testes, thyroid, and penis), Neonatal/Adult Transvaginal, Peripheral Vessels and Musculo-skeletal (superficial and conventional). The system also provides for the measurement of anatomical structures that provide information that is used for clinical diagnosis purposes. The Siemens Aux CW transducer is a non-imaging continuous wave transducer indicated for use in transthoracic/cardiac adult and pediatric applications as well as continuous wave spectral Doppler echocardiography.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc.·Product code ITX·March 21, 2009
The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose, WB and SPECT applications. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to give the system SPECT functionality, with attenuation correction. The Symbia T2 integrates state-of-the-art SPECT and high quality dual slice spiral CT to give the system full functionality for all SPECT-only, SPECT-CT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia T6 integrates state-of-the-art SPECT and high quality six slice spiral CT to give the system full functionality for all SPECT-only, SPECT-CT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. The Symbia T16 integrates state-of-the-art SPECT and high quality sixteen slice spiral CT to give the system full functionality for all SPECT-only, SPECT-CT, or stand-alone CT diagnostic applications in Oncology, Neurology, and Cardiology. For the Symbia T16/T6/T2, the ultra fast multi-slice spiral CT maximizes confidence in diagnostic stand-alone CT, as well as precise attenuation correction and anatomical mapping. Acquisitions can be performed with either the CT preceding the nuclear acquisition or vice versa. Indications for use: SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV. CT: The CT component is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial place taken at different angles or spiral planes taken at different angles. SPECT+CT: Perform CT scans and nuclear imaging studies within the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·October 8, 2014
Plandent Oy
Importer
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MedEnvoy Global BV
Importer
🇳🇱 Netherlands·234 Manufacturers
CMC Medical Devices & Drugs SL
Authorized representative
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