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MAMMI (Models FP-0202 and FP-0203) is intended to obtain Positron Emission Tomography (PET) images of breast to detect abnormal metabolic activities, when the patient was injected with FDA approved PET agent. MAMMI should not be used for breast cancer screening.

MAMMI is a high spatial resolution, small field-of-view breast PET dedicated (PEM) imaging system, specifically developed for close-range, spot, i.e. limited field, imaging. MAMMI is a ring PET scanner, equipped with lutetium-containing gamma-ray detectors (LYSO), which collects gamma rays emitted by injected positron-emitting radiopharmaceuticals, and generates images corresponding to concentration of these radiopharmaceuticals in the body. MAMMI is designed to collect gamma rays from a patient's body part with high efficiency and resolution. In order to achieve this high efficiency, the detectors are positioned around and must cover the body part under examination.

This document is a 510(k) summary for the MAMMI device and does not contain the detailed study information required to answer your request about acceptance criteria and device performance. The summary states that "no new testing was performed as no hardware changes were made from the predicate device" for performance testing (Section H), and "No new clinical images have been included" (Section J).

Therefore, specific acceptance criteria and detailed study results proving the device meets those criteria are not provided in this document. The document refers to software testing as having been "rigorously verified and validated" and that "Test results indicated that MAMMI complies with its predetermined specification," but it does not present the specifications or the results in detail.

To answer your request, one would need access to the full 510(k) submission (K161631) and potentially the submission for the predicate device (K140996), which might contain the relevant performance data and clinical study details.

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MAMMI (Models: FP-0202 and FP-0203) is intended to obtain Positron Emission Tomography (PET) images of breast to detect abnormal metabolic activities, when the patient was injected with FDA approved PET agent. MAMMI should not be used for breast cancer screening.

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The provided text is a 510(k) clearance letter from the FDA for a device named MAMMI, an Emission Computed Tomography system. While it indicates the device's intended use and substantial equivalence, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. This type of information is typically found in the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot provide the requested information based on the given input.

Ask a specific question about this device