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 MFG/MD/2021/000124_a59e87f33b64ec5d8a0ab80c4bcf67ec_8139ec16714d1b07ac7b3e8bb831b233. This device is marketed under the brand name Revolution ACTs. The license holder is Wipro GE Healthcare Private Limited, and it is classified as Device Class Class C. The approving authority is Sub Zonal Bangalore.

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CDSCO Registered

Class Class C

PET/CT

UID: MFG/MD/2021/000124_a59e87f33b64ec5d8a0ab80c4bcf67ec_8139ec16714d1b07ac7b3e8bb831b233

Brand Name

Revolution ACTs

License Holder

Wipro GE Healthcare Private Limited

Device Class

Class C

Approving Authority

Sub Zonal Bangalore

Product Information

GE Discovery PET/CT systems are intended for head and whole-body attenuation corrected Positron Emission Tomography (Revolution ACTs) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. Discovery PET/CT systems are to be used by trained health care professionals for imaging the distribution of radio pharmaceuticals in the body for the assessment of metabolic (Revolution ACTs) and physiologic functions in patients of all ages. This can assist in the evaluation, diagnosis, staging, re-staging, and follow up of lesions, disease and organ function such as (Revolution ACTs) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery IQ system can also be used as a stand-alone head and whole-body multi-slice computed tomography (Revolution ACTs) diagnostic imaging systems