Leksell Stereotactic System - India CDSCO Medical Device Registration
Leksell Stereotactic System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000568_8bcee24df8af264d2f5b4f054dc1b8b3_2a9a3e4f3da5aca8be9657a5cbf0c72b. This device is marketed under the brand name Leksell Vantage Stereotactic System. The license holder is ELEKTA MEDICAL SYSTEMS INDIA PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
Leksell Vantage Stereotactic System
License Holder
ELEKTA MEDICAL SYSTEMS INDIA PRIVATE LIMITEDDevice Class
Approving Authority
CDSCO
Product Information
The intended purpose of Leksell® Stereotactic System is target localisation and fixation of the patient head in a coordinate system in order to perform stereotactic neurosurgical procedures; for example deep brain stimulation, lesioning, biopsies, targeted injections, aspirations and minimal invasive tumour treatments. In addition, the coordinate frame is intended to be used for target localisation and head fixation during intracranial stereotactic radiosurgery with the Leksell Gamma Knife.
