X-Ray Machine
- UID
- MFG/MD/2021/000264_ec02968487877db8d2077c15cfbec622_2b75bc9f0165ed135edaf0e31e17f755
- 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
- This product is intended to be installed, used and operated by adequately trained, qualified and authorized healthcare professionals such as physicians, surgeons, cardiologists, radiologists and technologists, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the system. The system is used for radiologic guidance and visualization during diagnostic, interventional and surgical procedures on patients. The patients are all patients except babies, within the limits of the system. The system is to be used in and outside the operating room, in a sterile as well as nonsterile environment with a variety of procedures. 2D application areas: • Orthopaedic • Neuro • Abdominal • Vascular • Thoracic • Guidance during endoscopy • Foreign body removal • Needle biopsy localizations • Combinations with fluoro navigation systems • Combinations with lithotripsy systems • Pain management • Cardiac interventions
X-Ray Machine is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000264_ec02968487877db8d2077c15cfbec622_2b75bc9f0165ed135edaf0e31e17f755. 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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