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Patient positioning for Imaging and Radiotherapy - India CDSCO Medical Device Registration

Patient positioning for Imaging and Radiotherapy is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001142_8b5522e4c26f03d4c7727d32127beb8a_b65bed5f977cee770db06153cf2e359f. This device is marketed under the brand name Align RT Plus. The license holder is Taevas Life Sciences Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Patient positioning for Imaging and Radiotherapy
UID: IMP/MD/2023/001142_8b5522e4c26f03d4c7727d32127beb8a_b65bed5f977cee770db06153cf2e359f

Brand Name

Align RT Plus

Device Class

Class C

Approving Authority

CDSCO

Product Information

The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocenter, and to withhold the beam automatically during radiation delivery. For cranial treatments, a manual head adjuster is included which can be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations. AlignRT Plus is also used to track the patientโ€™s respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment. Patient contour data can be extracted and exported from the data acquired for the purpose of treatment planning. AlignRT Plus can be calibrated directly to the treatment beam isocenter and in turn assists in performing quality assurance on MV, kV imagers, room lasers and the treatment couch. AlignRT Plus is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation is indicated.

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