Ultrasound Systems - India CDSCO Medical Device Registration

Ultrasound Systems is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000251_946b1ce486caed07d4297a967f8195ec_3c4d6eef1687073bf7697ae38ed1e4d3. This device is marketed under the brand name Site~Rite Prevue. 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 Systems

UID: IMP/MD/2022/000251_946b1ce486caed07d4297a967f8195ec_3c4d6eef1687073bf7697ae38ed1e4d3

Brand Name

Site~Rite Prevue

License Holder

Bard India Healthcare Pvt. Ltd.

Device Class

Class C

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 • Small Organ (Site~Rite Prevue) • Musculo-skeletal (Site~Rite Prevue) • Cardiac (Site~Rite Prevue),3CG Diamond Tip Confirmation System(Site~Rite Prevue)-This is a Software Application Activation Code applicable to the Site Rite 8 Ultrasound Computing Platform. The software is indicated for guidance. and positioning of Peripherally Inserted Central Catheters (Site~Rite Prevue). Provides real-time PICC tip location information by using passive magnet tracking and the patient's cardiac electrical activity