Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard …
FDA 510(k)Class II (US FDA 510(k))
by Qfix
Identifiers
- 510(k) Number
- K160627 FDA 510(k)
- FDA Product Code
- IYE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Symphony Patient Transport System is a modular patient transfer and positioning solution designed for radiology and radiation therapy workflows. It includes a patient trolley, transfer surfaces, and specialized components tailored for brachytherapy procedures, ensuring secure and efficient patient movement between imaging, treatment, and procedural areas.
The system is supplied as a reusable, non-sterile medical device intended for use in clinical settings such as radiology departments and radiation oncology suites. Components are designed for compatibility with MRI environments and are available in standard and specialized transfer surface configurations, including a head/neck transfer surface for precise positioning. Authorized for use in the U.S. under FDA 510(k) clearance (K160627), the Symphony system adheres to regulatory standards for Class II medical devices (IYE product code).
Frequently asked questions
What is the Symphony Patient Transport System designed for?
The Symphony Patient Transport System is specifically engineered for seamless patient transfer and precise positioning in radiology and radiation therapy workflows. It integrates with imaging, treatment, and procedural areas to streamline workflows, particularly in brachytherapy procedures where accurate patient alignment is critical. The modular design allows for flexibility in adapting to different clinical needs, such as MRI-compatible environments.
Is the Symphony Patient Transport System reusable or single-use?
The Symphony Patient Transport System is supplied as a reusable, non-sterile medical device. This design choice aligns with clinical workflows where devices undergo routine cleaning and disinfection between uses, reducing waste and operational costs. Reusability also supports long-term cost efficiency for healthcare facilities.
What transfer surfaces are included in the Symphony system?
The system includes a standard transfer surface for general use and a specialized Portrait (Head/Neck) Transfer Surface designed for precise positioning of the head and neck region. These surfaces are modular and compatible with the patient trolley, allowing clinicians to select the appropriate configuration based on the procedure requirements. The modularity ensures adaptability across various clinical scenarios.
Can the Symphony Patient Transport System be used in MRI environments?
Yes, the components of the Symphony Patient Transport System are explicitly designed for compatibility with MRI environments. This feature is critical for radiology departments where patients frequently transition between imaging and treatment areas, ensuring safe and uninterrupted workflows without compromising imaging quality or patient safety.
How is the Symphony system authorized for use in the U.S.?
The Symphony Patient Transport System holds FDA 510(k) clearance (K160627), confirming its substantial equivalence to a predicate device under the IYE product code for Class II medical devices. This regulatory pathway ensures the system meets U.S. safety and performance standards for radiology and radiation therapy applications, including brachytherapy procedures.
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: Symphony Brachytherapy - OIS, Symphony Patient Transfer | CQ Medical, PDF Product Guide & User Manual, Symphony Patient Transport System, Symphony Patient Trolley, Symphony ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160627 | Class II | Active |
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Manufacturer
- Manufacturer
- Qfix
Sources (1)
- FDA 510(k) K160627 24 fields · synced Oct 1, 2026