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Delta4 Insight is a software intended to provide quality assurance of radiotherapy treatment dose calculation. Delta4 Insight is not a treatment planning system or a radiation delivery device. Information provided by Delta4 Insight shall not be used to directly modify or influence radiation treatments. Delta4 Insight is to be used radiation oncology personnel for quality assurance purposes.

Delta4 Insight is software specifically design for quality assurance of radiotherapy treatment plans generated by a treatment planning system. The device calculates a secondary dose calculation via an independent Monte-Carlo based dose calculation software and compares this to the treatment planning system dose. The device is used as a secondary check for the results of a TPS and not for comparison with a measurement. Delta4 Insight is a software module within the General Delta4 software. The software module is independent of all other software modules within the Delta4 software. The device is NOT a treatment planning system or a radiation therapy delivery device. It is only used by trained radiation therapy oncology personnel for the purposes of quality assurance in a hospital setting. Insight supports treatments with MV photons. No other radiation type is supported.

The intended use of the device is • quality assurance of patient specific treatment delivery prior to the treatment in IMRT (including VMAT) and 4DRT (e.g. respiratory gating and tumour tracking). • quality assurance of the radiation delivery system.

The device consists out of matrices of semiconductors embedded in a phantom. These matrices are inserted into the radiation field of a medical linear accelerator. If radiation from a radiotherapy treatment field) hits the semiconductors a signal is created and transferred to a computer where it is analysed and among others compared with the intended dose distribution. The new device Delta4 Phantom+ MR is equivalent in form and function to the cleared device Delta4 Phantom+, but has been verified as an MR-conditional product.

The intended use of the device is - quality assurance of patient specific treatment delivery during and before external radiotherapy treatment, including IMRT, VMAT and 4DRT (respiratory gating and tumour tracking) - quality assurance of the radiation delivery system.

The device is an instrument specifically designed to check delivered treatment plans by medical accelerator systems used for radiation therapy applications for quality assurance (QA) purposes. The device consists of a 2-dimensional matrix of semiconductors and associated acquisition, display and analysis computer programs. It is a quality assurance (QA) device enabling detailed mapping of therapeutic radiation dose distributions. This dose information is used in both quantitative and subjective assessments of the performance of radiation therapy treatment planning systems and therapeutic radiation delivery systems. The detector matrix is inserted into the radiation field of a medical linear accelerator. If radiation (from a radiotherapy treatment field) hits the detectors a signal is created and transferred to a computer where it is evaluated (e.g. by comparing planned with measured dose distributions).

The intended use of the device is: · quality assurance of patient specific treatment delivery prior to the treatment in IMRT (including VMAT) and 4DRT (e.g. respiratory gating and tumour tracking). · quality assurance of the radiation delivery system.

The device consists out of matrices of semiconductors embedded in a phantom. These matrices are inserted into the radiation field of a medical linear accelerator. If radiation (from a radiotherapy treatment field) hits the semiconductors a signal is created and transferred to a computer where it is analysed and among others compared with the intended dose distribution.

The intended use of Delta4 is quality assurance of patient specific treatment delivery prior to the treatment in IMRT and 4DRT (respiratory gating and tumor tracking).

The new device consists out of: - software . - . phantom - Detector arrays. . - Multi-channel electrometer . - Connection cables . When measurements are to be performed the device is typically put on the patient table (or couch). Then the device is exposed typically from different angles.