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The Elekta Synergy™ System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

The Elekta Synergy™ System is an enhancement to the previously reported Precise Treatment Systems Digital Accelerator (formally designated the SL/SLi Series, D.C. K963624) and its commercially available options.

The EOS iViewGT™ Electronic Portal Imaging Device (EPID), as with the predicate iView, is intended to be used with radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

The iViewGT™ EPID is an enhancement to the existing iView Electronic Portal Imaging Device which has previously been cleared for commercial distribution under D.C. K981790. These devices have an established and proven track record for safety. The primary reason for this modification to support solid state detectors for image acquisition. The iViewGTTM EPID does not raise additional types of safety or effectiveness considerations.

The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

The RT Desktop is an enhancement to the SL/SLi Interface (Javelin) which has previously been cleared for commercial distribution. This device has an established and proven track record for safety. The enhancement contains industry standard computer components to address the issue of component obsolescence currently associated with SL/SLi interface (Javelin). The RT Desktop does not raise additional types of safety or effectiveness considerations.

The FOS iView EPID, as with the predicate SKI 100, is intended to be used with radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.

The iView EPID is an enhancement to the existing SRI 100 electronic portal imaging device which has previously been cleared for commercial distribution. The primary reason for the introduction of this device is to address obsolescence issues associated with the image acquisition components and the computer hardware/operating system.