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_18003ff0809c2395a1fc9af4e43e9d7a. 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_18003ff0809c2395a1fc9af4e43e9d7a

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 used and operated by adequately trained, qualified and authorized healthcare professionals such as physicians, surgeons, radiologists and technologists, who have full understanding of the safety information as well as the capabilities and functions of the system. The system is used for radiological guidance and visualization during diagnostic and surgical procedures on patients. The patients can be all patients including children above the age of 8 years old who are within the limits of the system or as per the clinical judgment of the physician. The system is to be used inside and outside the operating room, in a sterile as well as non sterile environment with a variety of procedures. Application areas • Orthopedic surgeries • Pain management

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