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The GammaLoc System is a lesion localization accessory for the Dilon 6800 Gmma Camera. This stereotactic localization system gives the physician the capability to perform needle biopsy of lesions determined to be suspicious through gamma imaging.

The GammaLoc System is a lesion localization accessory to the Dilon 6800 Gamma Camera, previously cleared under K984466 (originally named Dilon 2000 Digital Gamma Camera). The Dilon Gamma Camera is a high resolution, small field of view, portable gamma camera for use in imaging radiopharmaceuticals consisting of three primary components: the detector head, the gantry arm and the mobile cabinet. There are no changes to the gamma camera in this submission.

The provided text describes the Dilon Technologies GammaLoc System, an accessory to the Dilon 6800 Gamma Camera for lesion localization in breast biopsies. However, the text does not contain a detailed study report or specific acceptance criteria with reported device performance metrics. It merely states that "Verification tests were performed on various components of the system to determine their individual performance. Validation tests were also performed on the integrated unit to determine the system performance."

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, details of MRMC studies, standalone performance details, type of ground truth used, or training set information because this information is not present in the provided document.

To answer your request comprehensively, I would need a different type of document, such as a detailed clinical study report, a performance validation report, or a more extensive 510(k) submission that includes such data.

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