Synchrony Respiratory Tracking System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K120233 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 Synchrony Respiratory Tracking System is a respiratory motion management device used in radiation therapy to track and synchronize treatment delivery with a moving target, such as a lesion within the thoracic cavity. It employs real-time monitoring and correlation modeling to account for respiratory motion, enabling precise targeting and reducing exposure to surrounding healthy tissue during treatment.
This system is designed for integration with radiation therapy platforms, including linear accelerators and CyberKnife systems, and operates in a clinical setting. It utilizes a wearable tracking vest (supplied in 5-packs) to monitor patient respiration and adjust beam delivery accordingly. The device is non-sterile, reusable, and does not contain MRI-compatible components. Authorized under FDA 510(k) clearance (K120233), it adheres to regulatory standards for Class II medical devices in radiation therapy.
Frequently asked questions
What is the primary purpose of the Synchrony Respiratory Tracking System in radiation therapy?
The Synchrony Respiratory Tracking System is designed to monitor and track respiratory motion in patients during radiation therapy. It uses real-time data from a wearable vest to correlate breathing patterns with treatment delivery, ensuring precise targeting of moving lesions—such as those in the thoracic cavity—while minimizing exposure to surrounding healthy tissue.
How is the wearable component of the Synchrony system supplied, and what does this mean for clinical workflow?
The wearable tracking vest is supplied in 5-packs, meaning each pack contains five individual vests ready for patient use. This pre-packaged format streamlines inventory management and reduces preparation time in the clinic, as healthcare providers can easily access and assign vests without additional assembly or sterilization steps.
Is the Synchrony Respiratory Tracking System reusable, and what implications does this have for infection control?
Yes, the Synchrony Respiratory Tracking System is designed for reuse, which aligns with standard infection control protocols for non-sterile medical devices. However, clinical staff must follow manufacturer-recommended cleaning and disinfection procedures between uses to ensure patient safety and device integrity.
Can the Synchrony system be used with any radiation therapy equipment, or are there specific platforms it integrates with?
The Synchrony Respiratory Tracking System is specifically designed for integration with radiation therapy platforms like linear accelerators and CyberKnife systems. Its compatibility is limited to these platforms, ensuring seamless synchronization of respiratory motion tracking with beam delivery.
What regulatory pathway was followed for FDA clearance of the Synchrony Respiratory Tracking System?
The Synchrony Respiratory Tracking System received FDA clearance through a 510(k) submission, classified as a Traditional review under the Radiology advisory committee (RA). The decision was based on a Substantially Equivalent determination to a predicate device, adhering to Class II regulatory standards for radiation therapy motion management.
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: SYNCHRONY RESPIRATORY TRACKING SYSTEM by ACCURAY INCORPORATED | FDA 510 ..., Synchrony® Tracking Vest (5-pack) - Accuray, Lung Target Tracking - Accuray
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120233 | Class II | Active |
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Manufacturer
- Manufacturer
- Accuray Incorporated
Sources (1)
- FDA 510(k) K120233 24 fields · synced Sep 19, 2026