Search Results

The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesons, turnors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The innages produced by the system can also be used by the physician to aid in radiotherapy to atmont planning and interventional radiology procedures.

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 isotopns 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 plane taken at different angles or spiral planes taken at different angles.

SPECT+CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.

Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT PERT CT and other imaging modalities.

The Siemens Symbia® system is combined X-Rav Computed Tomography (CT) and Emission Computed Tomography (SPECT) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The SPECT subsystem images and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for SPECT studies and precise anatomical reference for the fused SPECT and CT images.

The system maintains independent functionality of the CT and SPECT devices, allowing for single modality CT and / or SPECT diagnostic imaging.

The Symbia E and Symbia S series are gamma cameras used to view and analyze images of the human body and the distribution of administered radionuclides.

The Symbia T series have an additional CT system designed to produce crosssectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The Symbia T series allows healthcare facilities to carry out SPECT and CT studies using the same instrument.

The MI Workplace is a software workstation for use with nuclear medicine applications. The MI Applications software functions as the primary user interface for acquiring, viewing, manipulating, post-processing and archiving images from the Siemens family of dedicated SPECT, PET and SPECT/CT and PET/CT systems.

Enhancements in Symbia 4.0 include:

• 1. New optional acquisition method IQ•SPECT* for cardiac imaging
  • SMARTZOOM* collimator .
  • Cardio-centric acquisition .
  • IQ.SPECT reconstruction. .
• 2. New optional accessories; pediatric pallet, scintimamography pallet and radiation therapy pallet.
• 3. Single detector configuration of the commercially available Symbia E (K072567) gamma camera, Symbia E Single
• 4. Upgraded version of the MI Applications software (2009A)

The provided 510(k) summary for the Symbia 4.0 does not include a detailed study or acceptance criteria table typically found in performance testing sections. This document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's indications for use and safety measures.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a specific study is not available within this document.

The document states:

• "Risk Management is ensured via a risk analysis in compliance with ISO 14971 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product."
• "Siemens Medical Solutions, USA Inc. adheres to recognized and established industry standards such as IEC 60601-1 series and 21 CFR 1020.30 and 21 CFR 1020.33 to minimize electrical, mechnanical and radiation hazards."
• "Siemens considers that the proposed systems do not introduce new safety concerns, and is substantially the same in design, materials, energy sources and technology as the currently marketed systems. Siemens believes that the Symbia 4.0 systems are substantially equivalent to the predicate devices."

This indicates that Siemens is relying on its adherence to established standards and the substantial equivalence argument, rather than presenting a performance study with specific acceptance criteria in this summary.

In summary, the detailed study information requested is not present in the provided 510(k) summary.

Ask a specific question about this device

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.

The Symbia-E is a gamma camera used to view and analyze images of the human body and the distribution of administered radionuclides. This system is designed for whole-body oncology, neurology, cardiology and general diagnostic examinations. The Symbia-E is intended to be utilized by appropriately trained health care professionals to image and measure the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body.

The Symbia-E system which is the subject of this application is substantially equivalent to the commercially available e.cam gamma camera (K963983) and the commercially available Siemens Enhanced Imaging System (K041166).

The changes incorporated into Symbia E include modifications made to address obsolescence issues, cost reduction efforts and to change the industrial design of the system. Additionally, the system software has been updated (Syngo MI Applications 2007B).

The provided text is a 510(k) summary for the Symbia-E gamma camera. It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study demonstrating the device meets acceptance criteria, as this information is not present in the provided text.

Based on the information provided, here's what can be inferred:

• Device Name: Symbia-E
• Device Type: Gamma camera (Emission Computed Tomography System)
• Purpose: To view and analyze images of the human body and the distribution of administered radionuclides for various diagnostic examinations (oncology, neurology, cardiology, general diagnostics).
• Equivalence Claim: Substantially equivalent to previously cleared devices (e.g., e.cam gamma camera, Siemens Enhanced Imaging System, Syngo MI Applications 2007A, c.cam, c.cam-AC).
• Changes in Symbia-E: Modifications for obsolescence, cost reduction, industrial design change, and updated system software (Syngo MI Applications 2007B).
• Indications for Use: To detect or image the distribution of radionuclides in the body or organ, using planar imaging, whole body imaging, and tomographic imaging for isotopes with energies up to 588keV.
• Regulatory Outcome: FDA found the device substantially equivalent to legally marketed predicate devices.

To provide the requested information, you would need a different type of document, such as a test report, clinical study summary, or a more detailed section of the 510(k) submission that discusses performance data.

Ask a specific question about this device