B-400 Ceiling Mounted Possitioner, Model B-400
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K990055 FDA 510(k)
- FDA Product Code
- JAA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1650 FDA 510(k)
- Regulation Number
- 892.1650 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The B-400 Ceiling Mounted C-Positioner (Model B-400) is a mechanical support system classified as a system, x-ray, fluoroscopic, image-intensified. It is designed to securely hold X-ray tube and image intensifier assemblies in a fixed 180-degree ‘C’ configuration, facilitating precise fluoroscopic imaging in radiology procedures.
This device is intended for ceiling-mounted installation in radiology settings and is intended for single-use or reusable applications depending on facility protocols. It has received FDA 510(k) clearance (K990055) under the Radiology advisory panel and is classified as a Class II medical device. No specific sterility or MRI safety information is provided in the available data.
Frequently asked questions
What is the primary purpose of the B-400 Ceiling Mounted Positioner in a radiology setting?
The B-400 Ceiling Mounted Positioner is designed to securely hold X-ray tube and image intensifier assemblies in a fixed 180-degree ‘C’ configuration. This setup facilitates precise fluoroscopic imaging, ensuring stable positioning for accurate radiographic procedures in radiology.
Is the B-400 Ceiling Mounted Positioner intended for single-use or reusable applications?
The device is intended for either single-use or reusable applications, depending on the facility’s established protocols. There is no specific sterility information provided, so facilities must follow their own guidelines for cleaning, disinfection, or disposal.
How is the B-400 Ceiling Mounted Positioner installed in a radiology department?
The B-400 is specifically designed for ceiling-mounted installation in radiology settings. It is not a portable device, so it must be permanently affixed to the ceiling to support the X-ray tube and image intensifier assemblies in the required ‘C’ configuration.
What regulatory pathway was followed for FDA clearance of the B-400 Ceiling Mounted Positioner?
The B-400 received FDA clearance through a 510(k) submission, classified as substantially equivalent under the Radiology advisory committee (RA). The clearance number is K990055, and the device is categorized as a Class II medical device, indicating it poses moderate risk and requires compliance with specific regulatory controls.
Does the B-400 Ceiling Mounted Positioner come in multiple sizes or models?
The provided data only references Model B-400, so there is no information available on alternative sizes or variants. However, the device is designed for ceiling-mounted use in fluoroscopic imaging systems, suggesting compatibility with standard X-ray and image intensifier assemblies.
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: B-400 Ceiling Mounted Possitioner, Model B-400, B-400 CEILING MOUNTED POSSITIONER, MODEL B-400… - FDA.report, Omega B-400 Ceiling Mounted Possitioner, B-400 - allmed.wiki, PDF K990055 - B-400 Ceiling Mounted Possitioner, Model B-400, www.accessdata.fda.gov
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K990055 | Class II | Active |
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Manufacturer
- Manufacturer
- Omega Medical Imaging, Inc.
Sources (1)
- FDA 510(k) K990055 24 fields · synced Sep 19, 2026