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K Number
K990715
Device Name
SHIMADZU CEILING TUBE SUPPORT CH-30GH
Manufacturer
SHIMADZU CORP.
Date Cleared
1999-04-16

(43 days)

Product Code
KPR
Regulation Number
892.1680
Type
Abbreviated
Panel
RA
Reference & Predicate Devices
K934005
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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) .

Device Description

Not Found

AI/ML Overview

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.

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.