Diagnostic Ultrasound System - India CDSCO Medical Device Registration

Diagnostic Ultrasound System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000264_6c713851603c6184fa7947aa97f4294f_490dd62b97df40b2f8a14e63d044e70d. This device is marketed under the brand name Affiniti Diagnostic Ultrasound System. The license holder is Philips India Limited, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered

Class Class C

Diagnostic Ultrasound System

UID: MFG/MD/2021/000264_6c713851603c6184fa7947aa97f4294f_490dd62b97df40b2f8a14e63d044e70d

Brand Name

Affiniti Diagnostic Ultrasound System

License Holder

Philips India Limited

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

The intended use of the Affiniti series ultrasound systems is diagnostic ultrasound imaging and fluid flow analysis of the human body with the following Indications for Use: • Abdominal, Cardiac Adult, Cardiac other (Affiniti Diagnostic Ultrasound System), Cerebral Vascular, Cephalic (Affiniti Diagnostic Ultrasound System), Cephalic (Affiniti Diagnostic Ultrasound System), Fetal/Obstetric, Gynecological, Intraoperative (Affiniti Diagnostic Ultrasound System), Intraoperative (Affiniti Diagnostic Ultrasound System), Musculoskeletal (Affiniti Diagnostic Ultrasound System), Musculoskeletal (Affiniti Diagnostic Ultrasound System), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Affiniti Diagnostic Ultrasound System), Transesophageal (Affiniti Diagnostic Ultrasound System), Transrectal, and Transvaginal. • The clinical environments where the systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients

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Brand: Affiniti Diagnostic Ultrasound System

Philips India Limited