(139 days)
The NL4000 BodyTom Elite CT system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 85cm aperture.
The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast.
BodyTom Elite CT system can be used for low dose lung cancer screening. The screening must be performed in compliance with the approved and established protocols as defined by professional medical societies.
*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011: 365:395-409) and subsequent literature, for further information.
The BodyTom Elite is an improved version of BodyTom computed tomography (CT) system providing enhanced functionality. It still has the same high resolution, multi row, 85cm bore and 60cm field of view. The lightweight translating gantry consists of a rotating disk with a solid state x-ray generator, solid state detector array, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation) and stepper drive system (translation). The power system consists of batteries which provide system power while unplugged from the charging outlet. The system has the necessary safety features such as the emergency stop switch, x-ray indicators, interlocks, patient alignment laser and 110% x-ray timer. The gantry has retractable rotating caster wheels and electrical drive system so the system can be moved easily to different locations.
Here's an analysis of the acceptance criteria and study information provided, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria and their corresponding performance values in a direct numerical table for the entire device. However, it does list several image quality parameters that are important for Low Dose CT Lung Cancer Screening (LDCT LCS) and the general use of CT, along with reasons for their inclusion. The performance is stated as meeting all image quality criteria used for testing the predicate device.
Image Quality Parameters Relevant to LDCT LCS and General CT Use (Implicit Acceptance Criteria)
| Imaging Parameter | Reason for Inclusion / Implicit Criterion | Reported Device Performance |
|---|---|---|
| Modulation Transfer Function (MTF) | Describes the size of the smallest object that can be seen with large difference in CT value. Needs at least 2mm sampling rate or resolution of at least 5 lp/cm; 8 lp/cm recommended for detecting 4mm objects. | "The BodyTom Elite scanner successfully demonstrated that it has comparable image quality as the predicate device and meets all the image quality criteria that are used for testing the BodyTom as it passed all QA requirements." (Implies it meets the 5-8 lp/cm recommendation). Explicitly, the Spatial Resolution MTF at 0% is given as 17.5 lp/cm (matches predicate). |
| Slice Thickness | Determines the smallest size that can be seen in scan direction. Needs to be thin enough to allow identification of objects of at least 4.0 mm in diameter. ACR recommends under 2.5 mm. | "The BodyTom Elite scanner successfully demonstrated that it has comparable image quality as the predicate device and meets all the image quality criteria that are used for testing the BodyTom as it passed all QA requirements." (Implies it meets the |
§ 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.