TrueBeam-TrueBeam STx-Edge
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K162472 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 TrueBeam STx-Edge is a linear accelerator, classified as a medical radiation device designed for high-precision external beam radiotherapy. It delivers focused radiation therapy to treat malignant and benign conditions, including cancers and other targeted tissue pathologies, with advanced imaging and treatment planning capabilities.
This device is supplied as a reusable, hospital-based system and is regulated under FDA 510(k) clearance and EU MDR. It operates in clinical radiology settings and is intended for use in environments where MRI safety is not a primary concern. The system is authorized for multiple configurations, as indicated by the associated FEI numbers, and requires proper installation, maintenance, and calibration to ensure safe and effective operation.
Frequently asked questions
What types of medical conditions is the TrueBeam STx-Edge designed to treat, and how does it achieve precision in therapy?
The TrueBeam STx-Edge is a linear accelerator specifically designed for high-precision external beam radiotherapy, targeting both malignant (cancerous) and benign (non-cancerous) tissue pathologies. It delivers focused radiation to treat conditions like cancers while minimizing exposure to surrounding healthy tissue. The device achieves precision through advanced imaging and treatment planning capabilities, ensuring accurate delivery of radiation doses to the intended area.
Is the TrueBeam STx-Edge a single-use or reusable device, and what does this mean for maintenance and installation?
The TrueBeam STx-Edge is a reusable, hospital-based system, meaning it is installed permanently in clinical radiology settings rather than being discarded after use. This design requires proper installation, regular maintenance, and calibration to ensure safe and effective operation over its lifespan, as outlined in the manufacturer’s guidelines.
What regulatory pathways does the TrueBeam STx-Edge follow in the U.S. and Europe, and how does this affect its use?
In the U.S., the TrueBeam STx-Edge is regulated under FDA 510(k) clearance, classified as a Class II medical device (device class: 2) and filed under the Radiology advisory committee (RA). In Europe, it complies with EU MDR (Medical Device Regulation). These pathways ensure the device meets safety and performance standards before clinical use, but they do not define its intended clinical applications—only that it is authorized for high-precision radiotherapy in environments where MRI safety is not a primary concern.
How many configurations or models of the TrueBeam STx-Edge are available, and what does this mean for customization in a clinical setting?
The TrueBeam STx-Edge is authorized for multiple configurations, as indicated by the extensive list of FEI numbers (e.g., 3002619595, 3013410552, etc.). These FEI numbers correspond to different technical or functional variants, allowing healthcare facilities to select or customize the system based on specific clinical needs, such as beam energy, imaging capabilities, or treatment planning software. Each configuration must still adhere to the device’s core purpose of delivering precise external beam radiotherapy.
What kind of environment is the TrueBeam STx-Edge intended for, and are there any specific safety considerations for its use?
The TrueBeam STx-Edge is intended for use in clinical radiology settings, particularly where MRI safety is not a primary concern. This means it is designed for standard radiation therapy rooms rather than hybrid environments combining radiation and MRI. Safety considerations include ensuring proper installation, adherence to manufacturer guidelines for maintenance, and compliance with radiation safety protocols to protect patients and staff during treatment.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K162472 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (2)
- FDA 510(k) K162472 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026