Ultrasound System
- UID
- IMP/MD/2022/000565_3a9c379a2b7d40000a6f431e218b71a8_8e2e567c9f6f79ee59918608ebbb4354
- Device class
- Class C
- Brand name
- Site~Rite8 Ultrasound System
- License holder
- Bard India Healthcare Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- The Site~Rite® 8 Ultrasound System is intended for diagnostic ultrasound imaging of the human body. Specific clinical applications include: • Pediatric • Peripheral Vessel and Vascular access • Small Organ (Site~Rite8 Ultrasound System) • Musculo-skeletal (Site~Rite8 Ultrasound System) • Cardiac (Site~Rite8 Ultrasound System) Typical examinations performed using the Site~Rite® 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
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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