Shimadzu Ceiling Tube Support CH-30GH
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K990715 FDA 510(k)
- FDA Product Code
- KPR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Shimadzu Ceiling Tube Support CH-30GH is a ceiling-mounted tube support system used in clinical radiology settings. It functions as a mechanical support structure to position an X-ray tube for patient imaging.
The device is operated by trained radiology personnel to facilitate the alignment of the X-ray source relative to the patient. It is a Class II device with product code KPR and received FDA 510(k) clearance on April 16, 1999.
Frequently asked questions
What is the Shimadzu Ceiling Tube Support CH-30GH used for?
The Shimadzu Ceiling Tube Support CH-30GH is a ceiling-mounted mechanical support system used in clinical radiology settings to position an X-ray tube for patient imaging. It facilitates the alignment of the X-ray source relative to the patient when operated by trained radiology personnel.
What is the regulatory status of the Shimadzu Ceiling Tube Support CH-30GH?
The Shimadzu Ceiling Tube Support CH-30GH is a Class II medical device with product code KPR that received FDA 510(k) clearance on April 16, 1999. It was determined to be substantially equivalent to other legally marketed devices.
How is the Shimadzu Ceiling Tube Support CH-30GH supplied and stored?
The device is supplied as a ceiling-mounted tube support system designed for clinical radiology settings. While specific storage instructions are not provided in the device data, it should be stored according to standard medical equipment protocols to maintain functionality and safety.
Is the Shimadzu Ceiling Tube Support CH-30GH reusable or single-use?
The device data does not specify whether the Shimadzu Ceiling Tube Support CH-30GH is designed for single-use or multiple uses. As a mechanical support system for ceiling mounting, it is likely intended for long-term use in clinical settings, but specific reuse guidelines would need to be confirmed with the manufacturer.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SHIMADZU CEILING TUBE SUPPORT CH-30GH - Innolitics, K990715 - SHIMADZU CEILING TUBE SUPPORT CH-30GH | FDA 510(k), PDF K990715 - Shimadzu Ceiling Tube Support Ch-30gh
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K990715 | Class II | Active |
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Manufacturer
- Manufacturer
- Shimadzu Corp.
Sources (1)
- FDA 510(k) K990715 24 fields · synced Sep 25, 2026