(104 days)
The ECAM SCINTRON Gamma Camera System for diagnostic nuclear medicine is used to perform static, dynamic and gated studies (non positron emitting tomography), as well as SPECT or planar procedure on standing, seated or recumbent patients.
The ECAM SCINTRON Gamma Camera System is a remanufactured Siemens Gamma Camera with MiE Workstation. It is designed for diagnostic nuclear medicine used to perform static, dynamic and gated studies (non positron emitting tomography), as well as SPECT or planar procedure on standing, seated or recumbent patients.
The ECAM SCINTRON Gamma Camera System is substantially equivalent to the legally market device e.cam, K963983, from Siemens and our device SCINTRON, K101013.
The changes incorporated into the remanufactured ECAM Gamma Camera include economical and ecological issues. This closes the gap between more durable electronics and mechanics lifetimes and shortened development cycles.
This document is a 510(k) summary for the ECAM SCINTRON Gamma Camera System. It states that the device is substantially equivalent to a predicate device but does not include any acceptance criteria, performance data, or details of a study that proves the device meets specific acceptance criteria as requested in your input.
Therefore, I cannot provide the requested information from the provided text. The document focuses on regulatory approval based on substantial equivalence to existing devices rather than new performance studies with specific criteria.
§ 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.