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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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CDSCO Registered
Class Class C
Ultrasound System
UID: IMP/MD/2022/000565_3a9c379a2b7d40000a6f431e218b71a8_8e2e567c9f6f79ee59918608ebbb4354

Brand Name

Site~Rite8 Ultrasound System

Device Class

Class C

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: โ€ข Pediatric โ€ข Peripheral Vessel and Vascular access โ€ข Small Organ (Site~Rite8 Ultrasound System) โ€ข Musculo-skeletal (Site~Rite8 Ultrasound System) โ€ข 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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