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The SCINTRON workstation for diagnostic nuclear medicine is designed for acquiring, processing and reviewing data from all type of MiE and Siemens digital and analog gamma cameras. The SCINTRON is used to perform statis. dynamic and gated studies, as well as SPECT (non positron sitting tomography), whole body or planar procedure, on standing, seated or recumbent patients.

The SCINTRON is the modification and development of the SCINTRON IV. It is designed with Graphical User Interfaces for data acquisition, reviewing and processing of analog and digital Siemens gamma cameras. It controls static, dynamic, SPECT and whole body acquisitions. The SCINTRON uses industry standard and well tried PowerPC CPU on VMEbus which ensures long term support. Additionally to the clinical and networking programs, a variety of basic functions are available.

The provided text describes a 510(k) premarket notification for the SCINTRON, a gamma camera workstation. It clarifies that this notification is for a modification and development of the SCINTRON IV, designed for acquisition, reviewing, and processing of analog and digital Siemens gamma cameras.

However, the document does not contain information about specific acceptance criteria, performance data from a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training sets. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, operating principles, and fundamental technologies.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about specific studies using the information given in the extract. The document is a regulatory submission for substantial equivalence, not a detailed clinical or performance study report.

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