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 IMP/MD/2022/000565_3a9c379a2b7d40000a6f431e218b71a8_8e2e567c9f6f79ee59918608ebbb4354. This device is marketed under the brand name Site~Rite8 Ultrasound System. The license holder is Bard India Healthcare Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
Site~Rite8 Ultrasound System
License Holder
Bard India Healthcare Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
The Site~Riteยฎ 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include: โข Pediatric โข Peripheral Vessel and Vascular access โข Small Organ (Site~Rite8 Ultrasound System) โข Musculo-skeletal (Site~Rite8 Ultrasound System) โข Cardiac (Site~Rite8 Ultrasound System) Typical examinations performed using the Site~Riteยฎ 8 Ultrasound System include: Vessel: Assessment of vessels in the extremities and neck (Site~Rite8 Ultrasound System) leading to or coming from the heart, superficial veins in the arms and legs (Site~Rite8 Ultrasound System), and vessel mapping. Assessment of superficial thoracic vessels (Site~Rite8 Ultrasound System) Vascular Access: Guidance for PICC, CVC, dialysis catheter, port, PIV, midline, arterial line placement, access to fistula and grafts, and general vein and artery access Interventional: Guidance for biopsy and drainage Superficial: Assessment of breast, thyroid, parathyroid, testicle, lymph nodes, hernias, musculoskeletal procedures (Site~Rite8 Ultrasound System), soft tissue structures, and surrounding anatomical structures Cue Needle tracking system is intended to provide visual needle tracking to assist with ultrasound guided vascular access
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