TrueBeam, TrueBeam STx, EDGE, and VitalBeam (4.1)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K232870 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 (4.1) are linear medical accelerators designed for external beam radiotherapy. These devices deliver precise radiation doses to treat cancerous and non-cancerous tissues, utilizing advanced imaging and treatment planning technologies to enhance accuracy and reduce exposure to healthy tissue.
These systems are intended for use in clinical radiation oncology settings and are supplied as reusable medical equipment. They are classified as Class 2 devices under FDA regulations (product code IYE) and have received FDA 510(k) clearance through the Traditional pathway. The devices incorporate software updates from version 4.0 to version 4.1, maintaining compliance with regulatory standards for radiation therapy equipment.
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: K232870 FDA 510 (k) - TrueBeam | Varian Medical Systems, Inc., TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) (K232870) — FDA 510 (k ..., PDF Varian Medical Systems, Inc December 21, 2023 Lynn Allman Senior ..., TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) - FDA K232870
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 | K232870 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (2)
- FDA 510(k) K232870 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 26, 2026