Ultrasound System - India CDSCO Medical Device Registration
Ultrasound System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000179_3a9c379a2b7d40000a6f431e218b71a8_b372677c591c942b50b41c79120dabae. This device is marketed under the brand name Optima IGS 320. The license holder is Wipro GE Medical Device Manufacturing Private Limited, and it is classified as Device Class Class C. The approving authority is Sub Zonal Bangalore.
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Brand Name
Optima IGS 320
License Holder
Wipro GE Medical Device Manufacturing Private LimitedDevice Class
Approving Authority
Sub Zonal Bangalore
Product Information
The Versana Active is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Active clinical applications include: Fetal/Obstetrics, Abdominal (Optima IGS 320), Pediatric, Small Organ (Optima IGS 320), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric, Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/Pleural, Transcranial, Transrectal, Transvaginal, and Tissue Biopsy/Fluid Drainage. Versana Active ultrasound system is not intended for ophthalmic use or any use causing the acoustic beam to pass through the eye.
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