Varian Verification System (VVS)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K142268 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 Varian Verification System (VVS) is a quality assurance tool designed for linear medical accelerators, serving as a comprehensive platform to verify and validate the performance of radiation therapy equipment. It ensures precise calibration, consistency, and safety in radiation delivery systems used in radiology settings.
The VVS is intended for use in clinical environments where linear accelerators are deployed, providing reusable hardware and software components for routine and advanced quality checks. Authorized under FDA 510(k) and MDR compliance, it operates as a non-sterile, reusable device with no MRI-specific restrictions. Supplied as a complete system, it requires proper calibration and maintenance in accordance with manufacturer guidelines to sustain accuracy and reliability.
Frequently asked questions
What is the primary purpose of the Varian Verification System (VVS) in a clinical setting?
The Varian Verification System (VVS) is designed as a quality assurance tool specifically for linear medical accelerators used in radiation therapy. It ensures precise calibration, consistency, and safety of radiation delivery systems by providing reusable hardware and software components for routine and advanced quality checks in clinical environments.
Is the Varian Verification System (VVS) intended for single-use or reusable applications?
The VVS is explicitly described as a reusable device. It is supplied as a complete system and requires proper calibration and maintenance to maintain accuracy and reliability, as outlined by the manufacturer.
What regulatory pathways has the Varian Verification System (VVS) followed for approval?
The VVS has been authorized under both the FDA’s 510(k) pathway and the EU’s Medical Device Regulation (MDR). It was determined to be substantially equivalent to existing devices through the FDA’s traditional review process, with a decision date of October 2, 2014.
Does the Varian Verification System (VVS) have any restrictions related to MRI compatibility?
No, the VVS is explicitly stated to have no MRI-specific restrictions. It is designed for use in radiology settings where linear accelerators are deployed, ensuring compatibility with standard radiation therapy environments.
How is the Varian Verification System (VVS) supplied, and what maintenance is required?
The VVS is supplied as a complete system, combining reusable hardware and software components. To ensure sustained accuracy and reliability, it requires proper calibration and maintenance in accordance with the manufacturer’s guidelines, as outlined in the device description.
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: Varian Medical Systems – Wikipedia, Varian Medical Systems - Wikipedia, Login, Varian, a Siemens Healthineers Company, Varian Medical Systems Deutschland GmbH & Co. KG
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 | K142268 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (2)
- FDA 510(k) K142268 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026