(624 days)
The device is intended for use to identify by standard radiologic mark or techniques (X-Ray, fluoroscopy, CT, MRI) the location of a soft tissue abnormality such as a cyst, lesion, or tumor.
The TumorLocalizer MRI is a standard needle and hookwire device used for the localization of non-palpable lesions.
The provided document is a 510(k) summary for the "TumorLocalizer MRI" device, a surgical needle and hookwire device for localizing non-palpable lesions. It primarily addresses the regulatory approval process and states substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific performance criteria.
Therefore, I cannot provide the requested information based on the given input. The document focuses on regulatory compliance and not on detailed performance studies or statistical data.
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