Search Results

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