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Cadplan, Version 2.62. Radiation Therapy Treatment Planning System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K962950

by Varian Medical Systems, Inc.

Identifiers

510(k) Number
K962950 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)

CADPLAN, VERSION 2.62. RADIATION THERAPY TREATMENT PLANNING SYSTEM is a 3D radiation therapy treatment planning (RTP) system operating on UNIX technology. It processes patient anatomical data and beam parameters to model radiation dose distributions for photon, electron, and brachytherapy treatments. The system supports complex configurations including non-coplanar fields, multileaf collimators, and dynamic wedges.

It is classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls, and was cleared via FDA 510(k) under K962950. The device is supplied by Varian Medical Systems, Inc. and is intended for use in radiation oncology settings for treatment planning purposes.

Frequently asked questions

What is the CADPLAN, Version 2.62 Radiation Therapy Treatment Planning System intended for?

The CADPLAN, Version 2.62 system is intended for use in radiation oncology settings to process patient anatomical data and beam parameters to model radiation dose distributions for photon, electron, and brachytherapy treatments, supporting complex configurations such as non-coplanar fields, multileaf collimators, and dynamic wedges.

How is the CADPLAN, Version 2.62 system supplied and what technology does it operate on?

The CADPLAN, Version 2.62 system is supplied by Varian Medical Systems, Inc. and operates on UNIX technology as a 3D radiation therapy treatment planning system.

What regulatory pathway was used for the clearance of CADPLAN, Version 2.62 and what is its classification?

CADPLAN, Version 2.62 was cleared via the FDA 510(k) pathway under submission K962950 and is classified as a Class II device with product code IYE, falling under the Accelerator, Linear, Medical device category.

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: Cadplan, Version 2.62. Radiation Therapy Treatment Planning System ..., PDF K962950 Cadplan, Version 2.62. Radiation Therapy Treatment Planning System, CADPLAN, VERSION 2.62. RADIATION THERAP... (K962950) - FDA 510 (k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Varian Medical Systems, Inc.

Sources (1)

  • FDA 510(k) K962950 24 fields · synced Sep 19, 2026