Diagnostic Ultrasound System
- UID
- MFG/MD/2021/000264_6c713851603c6184fa7947aa97f4294f_490dd62b97df40b2f8a14e63d044e70d
- Device class
- Class C
- Brand name
- Affiniti Diagnostic Ultrasound System
- License holder
- Philips India Limited
- 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
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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