(86 days)
The Discovery NM 750b Gamma Camera is intended to measure and image the distribution of selected single photon emission radioisotopes in the human body to aid in the evaluation of lesions. The resultant images are intended to be reviewed by qualified medical professionals. The Discovery NM 750b Gamma Camera is intended for diagnostic imaging of the breast and other small body parts. The Discovery NM 750b Gamma Camera when used for breast imaging is intended as an adjunct to mammography or other breast imaging modalities (it is not intended for primary screening of the population). The Discovery NM 750b Gamma Camera is indicated for planar and dynamic planar scintigraphy in the energy range 80-200keV for the detection and display of radioisotope tracer uptake in patients of all ages.
The Discovery NM 750b is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. The device may include signal analysis and display equipment, patient and equipment supports, and accessories. The Discovery NM 750b is a high performance and compact planar nuclear imaging system, available in a dual head configuration or a single head configuration. This system is intended to measure and image the distribution of selected single photon emission radioisotopes in the breast and other small body parts in order to aid in the evaluation of lesions.
This 510(k) summary explicitly states that no clinical studies were submitted to support the substantial equivalence determination for the Discovery NM 750b. Therefore, there is no information about acceptance criteria or a study proving the device meets them in the provided text.
Specifically, the document states:
"Clinical Tests Submitted The 510(k) application does not contain information from GEHC sponsored clinical studies as provided for under 21CFR 54.2(e), and therefore does not require Clinical trials data."
Instead, substantial equivalence was determined based on:
"The proposed device has undergone bench testing that was designed to simulate clinical factors."
As such, I cannot provide the requested information from the provided text.
§ 892.1100 Scintillation (gamma) camera.
(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. 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 I (general controls).