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The Leksell Stereotactic System with disposable biopsy needle kit Indications for Use is a system intended for localization and diagnosis of intracranial disorders and their surgical treatment, including radiotherapy and stereotactic radiaton therapy

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The provided text is a 510(k) premarket notification letter from the FDA regarding the Elekta Leksell Stereotactic System. This document does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.

The letter serves as an FDA clearance, stating that the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements, but it does not include the detailed technical and clinical study information typically found in a 510(k) submission itself.

Therefore, I cannot provide the requested information based on the given text. To answer your questions, I would need access to the actual 510(k) submission document (K031980) which would contain the study details.

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