Search Results

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-7800T series is the same as that of predicate device SCT-7000TS W/FLUORO OPTION (K991553). Consequently, the indications for use of the SCT-7800T series are also the same as that of the SCT-7000TS W/FLUORO OPTION (K991553) and there are no additional indications.

Shimadzu Whole Body X-ray Computed Tomography Scanner SCT-7800 Series ( 3 models, minor variations)

I apologize, but the provided text from the FDA 510(k) clearance letter for the Shimadzu Whole Body X-ray Computed Tomography Scanner SCT-7800 Series does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance.

This document is a clearance letter, which states that the device is substantially equivalent to a predicate device and can be marketed. It does not typically include the specifics of performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert qualifications. These details would generally be found in the 510(k) submission itself, which is a much more extensive document.

Therefore, I cannot populate the table or answer the specific questions based solely on the text you've provided.

Specifically, the document only states:

• Device Name: Shimadzu Whole Body X-ray Computed Tomography Scanner SCT-7800 Series
• Intended Use: "This device is intended to be used in the examination of the whole body." and "This device is used optionally in CT Fluoroscopy."
• Predicate Device: SCT-7000TS W/FLUORO OPTION (K991553)
• Regulatory Class: II, 21 CFR 892.1750/Procode: 90 JAK

To provide the requested information, I would need access to the actual 510(k) submission document (K994431) or a summary of the performance testing within that submission.

Ask a specific question about this device