(36 days)
This device is intended to be used in the examination of the whole body.
The object of this device is total patient populations.
As mentioned at "Intended Use" in this clearance letter, the intended use of the SCT-7000TS W/FLUORO OPTION is the same as that of predicate device SCT-7000TS (K980837).
Consequently, the indications for use of the SCT-7000TS W/FLUORO OPTION are also the same as that of the SCT-7000TS(K980837) and there are no additional indications.
SCT-7000TS x-ray CT Scanner w/Fluoro Option
This is a 510(k) premarket notification for a CT scanner, not an AI/ML powered device. Hence, the traditional acceptance criteria, study design, and performance metrics for AI/ML devices, such as sensitivity, specificity, AUC, human-in-the-loop performance, etc., are not applicable in this context.
The provided document {0} is a letter from the FDA determining substantial equivalence for the Shimadzu Medical Systems SCT-7000TS x-ray CT Scanner w/Fluoro Option (K991553) to a legally marketed predicate device. The document {1} confirms the indications for use are the same as the predicate device (SCT-7000TS - K980837).
Therefore, I cannot extract the information required for the requested table of acceptance criteria and study details as this information is not present in the provided context for a CT scanner.
§ 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.