CDSCO UID IMP/MD/2022/000026_3a9c379a2b7d40000a6f431e218b71a8_87434598dc79e4c1cdc95fac960669da

Ultrasound System

Wipro GE Healthcare Private Limited·Device Class Class C·India CDSCO·Brand: Vscan Extend

Registration details

UID: IMP/MD/2022/000026_3a9c379a2b7d40000a6f431e218b71a8_87434598dc79e4c1cdc95fac960669da
Device class: Class C
Brand name: Vscan Extend
License holder: Wipro GE Healthcare Private Limited
Approving authority: CDSCO
Product information: Vscan Air is a battery-operated software-based general-purpose ultrasound imaging system for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training. The device is enabling visualization and measurement of anatomical structures and fluid including blood flow. Vscan Air’s pocket-sized portability and simplified user interface enables integration into training sessions and examinations in professional healthcare facilities (Vscan Extend), home environment, road/air ambulance and other environments as described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic follow-up, and triage. Vscan Air supports Black/ white (Vscan Extend), Color flow (Vscan Extend), Combined (Vscan Extend) and Harmonic imaging modes with both the curved and linear array transducers. With the curved array transducer of the dual headed probe solution, the specific clinical applications and exam types include: abdominal, fetal/obstetrics, gynecological, urology, thoracic/lung, cardiac (Vscan Extend), vascular/peripheral vascular, musculoskeletal (Vscan Extend), pediatrics, interventional guidance (Vscan Extend). With the linear array transducer of the dual headed probe solution, the specific clinical applications and exam types include: vascular/peripheral vascular, musculoskeletal (Vscan Extend), small organs, thoracic/lung, ophthalmic, pediatrics, neonatal cephalic, interventional guidance (Vscan Extend)