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The purpose of Panther Treatment Planning System is to provide a complete program for radiation therapy treatment planning. This includes computation, display, evaluation, and output documentation of radiation dose estimations to be submitted for independent clinical review and judgment prior to use. The device provides data in the form of display, hardcopy prints and/or plots to guide a physician in selecting the optimum patient treatment plan. Prowess products are radiotherapy treatment planning programs that allow radiation physicists, and dosimetrists to optimize the delivery of radiation in treating cancer and related diseases. The radiation therapy treatment planning system provides two-dimensional and three-dimensional planning software for external (photon and electron) treatments using linear accelerators and cobalt-60 beams. The software includes several optional modules which are licensed to users. IMRT – the IMRT module provides treatment planning for intensity-modulated radiation therapy (IMRT) using external photon beams. RealART – the RealART module is intended to provide online correction of the position and shape of the beam portals based on the images acquired on the treatment day when the patient is in the treatment position. ProArc – the ProArc module is intended to support treatment planning by creating treatment plans for intensity-modulated arc radiation therapy. Stereotactic – the Stereotactic module is intended to support highly advanced precision-targeted radiation planning.

Panther TPS is a three-dimensional treatment planning system for external beam radiation. The software is intended to assist in the relative positioning of radiation therapy treatment devices by predicting the three-dimensional isodose distributions that would be delivered for a particular device setting. It includes computation, display, evaluation and output documentation of radiation dose estimates to be submitted for independent clinical review and judgment prior to use. Panther TPS is a Microsoft Windows based treatment planning system that includes several modules, each of which has a specific function or series of functions. This significant change associated with the release of this version is a platform change, adding support for Windows Server.

Panther OIS is an information management system used to manage medical data and clinical workflow in a hospital or clinic. To support radiation oncology users, it allows the user to: - · Enter or import, modify, store and archive treatment plans and images from treatment planning systems. - · Import, view, manipulate, enhance, annotate, store, and archive radiological images. - · Select and provide radiation treatment plans to a radiation treatment delivery system for atment. - · Store and view treatment records provided by the radiation treatment delivery system.

Panther OIS is an information management system used to organize medical data and facilitate the clinic workflow in a hospital or clinic. It is built on the Windows system as standard thin client-server system with a centralized database. Panther OlS has incorporated and enhanced the previously cleared Prowess Panther OIS|R&V (K122616) into its framework so the user is able to: - Record patient related information, especially radiation treatment planning and records. ● - Schedule patients, medical resources and any type of activity. - Capture procedure codes that will be used for billing. - Generate reports for statistics purpose. - Complete their tasks easily using the new ribbon Ul that supports their workflow. - Import treatment plans - Record patient treatment histories - . Deliver treatment plans on radiation treatment delivery systems that have a DICOM interface for both external and stereotactic plans. - Import, access, store and archive radiological images and review images to verify delivered treatment. - The client is updated to a thin client so that it can be installed on more supported devices. - Support for stereotactic treatment workflow which is similar to the external beam workflow but using a shot concept instead of a beam/arc concept. Changes within the scope of this 510(k): - Addition of support for stereotactic planning ● - Addition of thin-client support, running resources stored on a central server instead of its localized hard drive - R&V-related functionalities have been removed

Panther Stereotactic is intended to support highly advanced precision-targeted radiation planning.

Panther Stereotactic is an optional software module that has been added to the existing Prowess Panther Treatment Planning System to support planning with multiple shots instead of beams/arcs. Each shot is defined as a full or partial arc of one or multiple radiation sources with different collimator sizes depending on the machine configuration depending on the delivery types. Stereotactic forward planning extends Prowess Panther's existing arc definition features to define shot parameters such as location, size and arc angles. Stereotactic inverse planning extends Prowess Panther's existing simulated annealing algorithm to find optimal shot parameters such as location, size and arc angles.