4D Integrated Treatment Console with Patient Accessory Verification System (PAVS)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K081036 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 4D Integrated Treatment Console with Patient Accessory Verification System (PAVS) is a radiation therapy treatment console designed to centralize control and monitoring of linear accelerators, multi-leaf collimators (MLCs), and on-board imaging systems. It integrates patient-specific data, including treatment plans and real-time positional verification, to enhance precision and safety during radiotherapy delivery. The system ensures accurate alignment and verification of patient accessories, reducing the risk of errors in treatment delivery.
This console is intended for use in radiation oncology settings and operates as a reusable, non-sterile medical device. It interfaces with linear accelerators and associated imaging modalities to provide a unified platform for therapy management. The device has received FDA 510(k) clearance (K081036) under the Special 510(k) program and is classified as a Class II medical device. No specific sterility or MRI safety requirements are noted in the regulatory data.
Frequently asked questions
What is the 4D Integrated Treatment Console with PAVS used for?
The 4D Integrated Treatment Console with Patient Accessory Verification System (PAVS) is designed to centralize control and monitoring of linear accelerators, multi-leaf collimators (MLCs), and on-board imaging systems in radiation oncology. It integrates patient-specific data, including treatment plans and real-time positional verification, to improve precision and reduce errors during radiotherapy delivery. This ensures accurate alignment and verification of patient accessories, enhancing overall treatment safety.
How is the 4D Integrated Treatment Console with PAVS supplied and is it sterile?
The device is supplied as a reusable, non-sterile medical console. It is not intended for single-use or sterile applications, as noted in the regulatory data. The console interfaces directly with linear accelerators and imaging systems, requiring proper setup and maintenance in a clinical environment.
Is the 4D Integrated Treatment Console with PAVS approved for specific regulatory pathways?
Yes, the 4D Integrated Treatment Console with PAVS has received FDA 510(k) clearance under the Special 510(k) program, specifically clearance number K081036. It is classified as a Class II medical device and is intended for use in radiation oncology settings. The clearance indicates it is substantially equivalent to a predicate device, meeting regulatory requirements for safety and effectiveness.
Does the 4D Integrated Treatment Console with PAVS require any special storage conditions?
The console is a reusable, non-sterile device, so it does not require sterile storage conditions. However, it should be stored in a clean, controlled environment to prevent contamination and ensure proper functionality. Follow manufacturer guidelines for maintenance, calibration, and environmental considerations to support long-term performance and compliance with clinical protocols.
What types of linear accelerators and imaging systems does the 4D Integrated Treatment Console with PAVS interface with?
The console interfaces with a variety of linear accelerators and associated imaging modalities, as indicated by the extensive list of OpenFDA registration numbers linked to linear accelerator devices. These include systems used for radiotherapy treatment planning and delivery, ensuring compatibility with common equipment in radiation oncology. The exact models may vary, but the console is designed to integrate seamlessly with standard linear accelerators and on-board imaging systems.
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: 4d Integrated Treatment Console With Patient Accessory Verification ..., 4D INTEGRATED TREATMENT CONSOLE (K091132) — FDA 510 (k) | Innolitics, 510(k) K081036 — 4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081036 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (1)
- FDA 510(k) K081036 24 fields · synced Oct 5, 2026