Identifiers
- 510(k) Number
- K001643 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 VARIS 1.4G is a Medical Linear Accelerator designed to generate high-energy charged particles, such as electrons and protons, for use in radiation therapy. As a charged-particle radiation therapy system, it accelerates particles to precise energies for targeted treatment of malignant and benign conditions, including oncology and radiosurgery applications. Its function relies on linear acceleration technology to deliver controlled radiation doses to clinical targets while minimizing exposure to surrounding tissues.
This device is intended for use in radiation oncology departments within hospital or clinic settings, where it is integrated into treatment planning systems for precise dose delivery. Supplied as a reusable, non-sterile medical device, the VARIS 1.4G adheres to Class II (Special Controls) regulatory standards under FDA 510(k) clearance (K001643). It operates within standard MRI safety guidelines for non-MRI environments and requires specialized training for operation and maintenance. Storage and handling follow manufacturer protocols to ensure calibration and performance integrity.
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: VARIS 1.4G (K001643) — FDA 510(k) | Innolitics, VARIS 1.4G (K001643) — FDA 510(k) | Innolitics, VARIS 1.4G (K001643) - FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K001643 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (1)
- FDA 510(k) K001643 24 fields · synced Oct 5, 2026