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The CH-30GH is used to take the radiography of patients in standing position or . lying position. The intended for use of the CH-30GH are also the same as of the predicate device of the CH-30GX (K934005) .

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This document does not contain the information requested regarding acceptance criteria, study details, or performance metrics for a medical device.

The provided text is a 1999 FDA 510(k) clearance letter for the Shimadzu Ceiling Tube Support, CH-30GH, and a separate "Intended Use Section" for the same device.

Here's what the document does contain:

• FDA Clearance: It states that the device (Shimadzu Ceiling Tube Support, CH-30GH) has been reviewed and determined to be substantially equivalent to a legally marketed predicate device (CH-30GX, K934005).
• Regulatory Class: Class II (21 CFR 892.1680 / Procode: 90 KPR).
• Intended Use: "The CH-30GH is used to take the radiography of patients in standing position or lying position." It also states the intended use is the same as the predicate device CH-30GX.
• Date: April 16, 1999.

Missing Information:

All the detailed information requested in the prompt, such as acceptance criteria, reported performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance, is not present in these documents. These types of details would typically be found in the premarket notification (510(k) submission) itself, specifically in performance testing or clinical data sections, which are not provided here.

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