(153 days)
This device is intended to be used in the examination of the whole body. / This device is used optionally in CT Fluoroscopy. / This device is operated and used by Physicians and X-ray technologist. / The object of this device is total patient populations. As mentioned at "Intended Use" in this clearance letter, the intended use of the SCT-7000TX W/FLUORO OPTION is the same as that of predicate device SCT-7000TX (K955255) except optional CT fluoroscopy . Consequently, the indications for use of the SCT-7000TX W/FLUORO OPTION are also the same as that of the SCT-7000TX (K955255) except optional CT fluoroscopy
SCT-7000TX X-ray CT Scanner with Fluoro Option
The provided documents are correspondence from the FDA regarding a 510(k) clearance for the Shimadzu SCT-7000TX X-ray CT Scanner with Fluoro Option (K984156), and an "Indications For Use" statement.
These documents do not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. They are administrative documents related to regulatory clearance based on substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information.
§ 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.