TrueBeam, TrueBeam STX, Edge and VitalBeam
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K252948 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, TrueBeam STX, Edge, and VitalBeam are linear accelerators designed for external beam radiotherapy. These devices deliver precise, high-energy photon and electron beams to treat malignant and benign conditions, including cancers and non-cancerous tumors, through advanced radiation therapy techniques such as intensity-modulated radiation therapy (IMRT), volumetric modulated arc therapy (VMAT), and stereotactic body radiation therapy (SBRT).
These systems are intended for use in radiation oncology departments within hospitals or specialized cancer centers. They are non-sterile, reusable medical devices classified as Class II under FDA regulations and comply with the Medical Device Regulation (MDR). Each model—TrueBeam, TrueBeam STX, Edge, and VitalBeam—may vary in configuration and capabilities but share core functionality for radiation delivery. Authorized under FDA 510(k) clearance and MDR compliance, they are regulated under the FDA’s 510(k) pathway and the EU’s MDR framework.
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 | K252948 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (2)
- FDA 510(k) K252948 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026