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SIDDHARTH-II is intended to perform image guided stereotactic radiotherapy for the lessons, tumors & conditions anywhere in the body where radiation treatment is indicated for adults and Pediatric patients. Integrated Radiation Field Analyser (RFA) of Siddharth-II is intended to collect beam data in water under the aspect of machine QA for the following purposes: - acceptance testing , periodic QA procedures, and/or commissioning of a radiation therapy system. - beam data analysis according to international therapy dosimetry protocols - acquisition, formatting and transfer of basic data to treatment planning systems The indication for use of Immobilization & Patient Positioning devices (IMPACT) is to immobilize the patient during treatment by providing appropriate support and comfort which in turn leads to precise treatment delivery.

SIDDHARTH-II, the subject device remains same as the most recently cleared predicate device SIDDHARTH-II (K210894). In addition, with the features and specifications of existing 510k cleared equipment, the Radiation Field analyzer (RFA) has been permanently integrated with gantry of Siddharth-II to perform beam data analysis as per international therapy dosimetry protocols. The integrated RFA is retracted and accommodated within the gantry of the radiation therapy equipment after performing data dosimetry operations. This provides an integrated solution for validating the performance of a radiation therapy equipment using an RFA which is in-built with the radiation therapy equipment that is primarily employed for providing radiation treatments to patients. The following functionalities can be achieved by using this RFA integrated with Siddharth-II. - . Acceptance testing, Commissioning and Periodic Quality Assurance Measurements for radiation beams emitted by radiation therapy equipment SIDDHARTH-II - . Beam data analysis according to international therapy dosimetry protocols - . Collection of beam data for Treatment Planning System The RFA setup consists of RFA electromechanical arm for 3-dimensional movement of radiation detector. Ion Chamber (Radiation Detector), Built-in Electrometer, RFA water tank and Water Reservoir. The design control procedures applied to the development of the SIDDHARTH-II and its modifications include requirements reviews, risk analysis, and verification and validation testing. The results of verification and validation activities demonstrate that the acceptance criteria have been met. All other features and technological characteristics of the SIDDHARTH-II remains as cleared by K210894.