PET/CT - India CDSCO Medical Device Registration

PET/CT is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000328_a59e87f33b64ec5d8a0ab80c4bcf67ec_9edcd453eb132db82c7fc988c3d16c41. This device is marketed under the brand name OMNI Legend. The license holder is Wipro GE Healthcare Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

PET/CT

UID: IMP/MD/2023/000328_a59e87f33b64ec5d8a0ab80c4bcf67ec_9edcd453eb132db82c7fc988c3d16c41

Brand Name

OMNI Legend

License Holder

Wipro GE Healthcare Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Omni Legend PET/CT system is intended for CT attenuation corrected, anatomically localized PET imaging of the distribution of positron-emitting radiopharmaceuticals. It is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The system is also intended for stand-alone, diagnostic CT imaging