(15 days)
The GE Optima NM/CT 640 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of turnors, planning, guiding, and monitoring therapy.
The GE Optima NM/CT 640 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging-enhancement features include an assortment of collimators, gating by physiological signals, and real-time automatic body contouring.
The GE Optima NM/CT 640 system includes an integrated CT, which is intended specifically for attenuation correction and anatomical localization purposes only, a processing and review. workstation, and may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages.
Utilizing the associated CT portion and post processing, the device can produce attenuation corrected SPECT images using CT-based attenuation maps, as well as functional and anatomical mapping images registered with the SPECT images for purposes of localization and fusion.
The device does not support stand-alone CT operation.
The Optima NM/CT 640 system is a combination of the Discovery NM630 gamma camera (K111445), the certified table from the Discovery NM/CT 670 (K093514) and a 4 slice CT subsystem containing previously certified components. It consists of two back-to-back gantries, a single table, a single power distribution unit, a console with single acquisition system and associated accessories (e.g. ECG gating. Table Extender. Head Holder, etc.). The system is delivered with a processing and review workstation (currently Xeleris 3-K093982). The system is intended to be in clinics or hospitals having normal HVAC controls.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) summary for the GE Optima NM/CT 640 system, which focuses on demonstrating substantial equivalence to predicate devices rather than reporting on specific performance studies against acceptance criteria.
The document states: "The Optima NM/CT 640 does not require clinical studies to support substantial equivalence." This indicates that no clinical performance study, as you've described, was conducted or presented in this filing for the purpose of demonstrating performance against acceptance criteria.
Therefore, I cannot provide the requested information.
§ 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.