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_17f5fe26a2a2ea28632a8b499ee02f6d. 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 Vivid T8 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by qualified and trained Healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab, and in private medical offices. The systems support the following clinical applications: Fetal/Obstetrics, Abdominal (Optima IGS 320), Pediatric, Small Organ (Optima IGS 320), Neonatal Cephalic, Adult Cephalic, Cardiac (Optima IGS 320), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Transcranial, Transesophageal, Transrectal, Transvaginal, Interventional guidance (Optima IGS 320), Intraoperative(Optima IGS 320). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD, B/Color/PWD, B/Power/PWD
Computed Tomography
Brand: Optima IGS 320
Wipro GE Medical Device Manufacturing Private Limited
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Brand: Optima IGS 320
Wipro GE Medical Device Manufacturing Private Limited
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Brand: Optima IGS 320
Wipro GE Medical Device Manufacturing Private Limited
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