X-Ray Machine - India CDSCO Medical Device Registration

X-Ray Machine is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000264_ec02968487877db8d2077c15cfbec622_67b6ec1da0fda19d6c4b311ff83b1d2e. 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

X-Ray Machine

UID: MFG/MD/2021/000264_ec02968487877db8d2077c15cfbec622_67b6ec1da0fda19d6c4b311ff83b1d2e

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

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

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