(381 days)
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head.
The Aquilion PRIME has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
The TSX-302A is an 80-row CT System that is intended to produce axial scans of the whole body to include the head. The TSX-302A is based upon the technology and materials of previously marketed Toshiba CT systems.
I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, or any studies conducted to prove the device meets said criteria. The document is a 510(k) summary for the TSX-302A, Aquilion Prime CT System, detailing its intended use, substantial equivalence to a predicate device, and regulatory information from the FDA. It does not include any performance data or 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.