(14 days)
The NL3000 CereTom is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 25cm field of view, primarily head and neck.
The NL3000 CereTom is a high resolution, 8 row, 32 cm bore, 25cm field of view, Computed Tomography System. The lightweight translating gantry consists of a rotating disk with a solid state x-ray generator, 3264-element solid state detector array, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, touch screen LCD display, power system, brushless DC servo drive system (disk rotation), and stepper drive system (translation). The power system consists of dry sealed batteries which provide system power while unplugged from the charging outlet. When plugged into an outlet the system charges the batteries with a line power drain of less than 1300 watts. The work station consists of a Sony Vaio laptop computer. The workstation software consists primarily of a certified off-the-shelf CT viewing system from a third party vendor. In addition the system has the necessary safety features such as emergency stop switch, x-ray indicators, interlocks, patient alignment laser, and 110 percent x-ray timer. It requires very little x-ray power in comparison to large bore systems to obtain equivalent CT image quality. The gantry has retractable 100mm diameter rotating caster wheels so the system can be moved easily to different locations.
The provided text is a 510(k) summary for the NeuroLogica NL3000 CereTom Computed Tomography System. It focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with performance metrics. Therefore, much of the requested information regarding acceptance criteria, study details, and performance statistics is not available in the provided text.
Specifically, the document primarily addresses:
- Device description and intended use.
- Comparison of technological characteristics with predicate devices (Philips Tomoscan M/EG, GE LightSpeed Ultra CT, Siemens SOMATOM Plus 4).
- General safety and effectiveness concerns, stating adherence to regulations and standards (e.g., 21 CFR Part 1020, UL60601-1, IEC 60601-1, EN 60601-1).
- A conclusion of substantial equivalence to the predicate devices based on design, material, functionality, and technology.
There is no information about a specific study with clearly defined acceptance criteria, reported device performance metrics against those criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details on training set size and ground truth establishment in the provided text.
The document is a submission for regulatory clearance based on substantial equivalence, which often means demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing new clinical study results with detailed performance metrics.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.