Acuity With Conebeam Computed Tomography
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K033339 FDA 510(k)
- FDA Product Code
- KPQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5840 FDA 510(k)
- Regulation Number
- 892.5840 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Acuity With Conebeam Computed Tomography is a system for radiation therapy simulation. It provides imaging capabilities for treatment planning and verification in radiology applications.
This device is supplied as a system and is regulated under FDA 510K clearance with product code KPQ. It is manufactured by Varian Medical Systems, Inc. and is available in various models as indicated by the multiple FEI numbers and registration numbers provided.
Frequently asked questions
What is the Acuity With Conebeam Computed Tomography used for?
The Acuity With Conebeam Computed Tomography is a system designed for radiation therapy simulation, providing imaging capabilities for treatment planning and verification in radiology applications.
How is the Acuity With Conebeam Computed Tomography supplied?
This device is supplied as a complete system and is manufactured by Varian Medical Systems, Inc. It is available in various models as indicated by the multiple FEI numbers and registration numbers provided.
What is the regulatory status of the Acuity With Conebeam Computed Tomography?
The Acuity With Conebeam Computed Tomography is regulated under FDA 510K clearance with product code KPQ. It received FDA clearance on December 30, 2003, and is classified as a Class II device.
What are the specifications of the Acuity With Conebeam Computed Tomography?
The device is a radiation therapy simulation system with conebeam computed tomography capabilities. It has multiple FEI numbers including 3002806900, 3007545404, 3015232217, 1000284313, 2916710, 1000123143, and 1219183, with corresponding registration numbers.
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: Acuity Brands - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K033339 | Class II | Active |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
Sources (1)
- FDA 510(k) K033339 24 fields · synced Oct 6, 2026