(55 days)
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.
Not Found
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.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.