(83 days)
The Volumax is used for whole body computed tomography.
Whole body computerized tomography.
The Volumax is a continuous rotation CT scanner consisting of a gantry, patient table, operator station and accessories. Its main characteristics are:
- Continuous rotation and Helix (spiral) scanning. .
- Simultaneous multi-slice scanning. .
- Minimum scan time of 0.3 second. .
- Minimum reconstruction time of 0.5 second. .
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) summary for the Volumax CT scanner, focusing on its intended use, features, predicate devices, and a statement of substantial equivalency. It highlights adherence to safety standards (GMP, IEC 601-1, 21 CFR Subchapter J) but does not detail performance metrics or studies to demonstrate them against specific acceptance criteria.
Therefore, I cannot provide the requested table and study details.
§ 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.