Search Results

declipseSPECT Viewer works in conjunction with a nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. declipseSPECT Viewer is intended to use the said detector and generate images of the distribution of radionuclides in the human body and determine the 3D localization of these radionuclides relative to surgical instruments by means of tracking technologies and image reconstruction techniques. The declipseSPECT Viewer is also intended to be used for hybrid nuclear medicine image viewing in-situ, such as SPECT/CT and PET/CT.

declipseSPECT Viewer may also be used intraoperatively or on pathological specimens if a protective cover is used to cover the nuclear uptake detector. dedipseSPECT Viewer may be used at the patient's bedside, or in an Emergency Room or Intensive Care Unit. The scan and operation of the system can be performed by medical staff, including technicians, nurses, physicist and physicians that are trained to use the system.

The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel.

Not Found

This document is a 510(k) clearance letter from the FDA for the "declipseSPECT Viewer" device. It does not contain the detailed information required to answer the prompt regarding acceptance criteria and performance studies.

The prompt asks for specific details about the study design (sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details), which are typically found in the summary of safety and effectiveness or in the full submission, not in the clearance letter itself.

Therefore, I cannot provide the requested information based solely on the provided text.

Ask a specific question about this device