B-350 Ceiling Mounted C-Positioner
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K970947 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-350 Ceiling Mounted C-Positioner is a ceiling-mounted fluoroscopic imaging system designed for radiography procedures. It features an isocentric C-arm configuration, enabling precise positioning and imaging of patients in various clinical settings, including orthopedics, cardiology, and general radiology.
This device is intended for use in hospital operating rooms, interventional suites, and radiology departments. It is supplied as a reusable medical device and requires proper maintenance and sterilization protocols. The B-350 is classified as a Class II device under FDA regulations (21 CFR 892.1650) and holds an FDA 510(k) clearance (K970947) for substantial equivalence to a predicate device. It is not MRI-safe and must be used in accordance with manufacturer guidelines.
Frequently asked questions
What clinical settings is the B-350 Ceiling Mounted C-Positioner primarily designed for, and how does its isocentric C-arm configuration benefit users?
The B-350 is designed for radiography procedures in hospital operating rooms, interventional suites, and radiology departments, serving specialties like orthopedics, cardiology, and general radiology. Its isocentric C-arm configuration allows for precise 360-degree patient positioning and imaging, reducing the need for repositioning and improving accuracy during procedures.
Is the B-350 Ceiling Mounted C-Positioner intended for single-use or reusable applications, and what maintenance is required?
The B-350 is a reusable medical device, meaning it is designed for repeated use in clinical settings. Proper maintenance and sterilization protocols must be followed to ensure safety, functionality, and compliance with manufacturer guidelines.
What regulatory pathway was followed for the FDA clearance of the B-350, and what does this mean for its use in clinical environments?
The B-350 received FDA clearance through a 510(k) submission (K970947) under the Traditional pathway, demonstrating substantial equivalence to a predicate device. This clearance confirms it meets FDA safety and effectiveness standards for Class II devices (21 CFR 892.1650) and can be legally marketed in the U.S. for its intended radiography applications.
Can the B-350 Ceiling Mounted C-Positioner be used in an MRI environment, and why is this important to note?
No, the B-350 is not MRI-safe, meaning it should never be used in proximity to MRI machines. This is critical because MRI environments involve strong magnetic fields that can damage non-MRI-compatible devices, posing risks to patients and staff.
How is the B-350 supplied, and are there multiple models or configurations available?
The B-350 is supplied as a ceiling-mounted fluoroscopic imaging system with an isocentric C-arm design, but the provided data does not specify distinct model variants or configurations beyond its core design. The OpenFDA registration numbers list multiple associated parts or accessories, but these are not described as separate models in the data.
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-350 CEILING MOUNTED C-POSITIONER - Innolitics, K970947 FDA 510 (k) - B-350 CEILING MOUNTED C-POSITIONER, Omega B-350 Ceiling Mounted C-Positioner - allmed.wiki, B-350 Ceiling Mounted C-positioner 510(k) FDA Premarket Notification ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K970947 | Class II | Active |
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Manufacturer
- Manufacturer
- Omega Medical Imaging, Inc.
Sources (1)
- FDA 510(k) K970947 24 fields · synced Sep 19, 2026