CT Scanner - India CDSCO Medical Device Registration

CT Scanner is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000638_3af2d76c83e8e9c9cdad250a7998a23d_6fcafea5daeac16f5588252357db89b5. This device is marketed under the brand name OmniTom Elite. The license holder is Schiller Healthcare India Pvt Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

CT Scanner

UID: IMP/MD/2021/000638_3af2d76c83e8e9c9cdad250a7998a23d_6fcafea5daeac16f5588252357db89b5

Brand Name

OmniTom Elite

License Holder

Schiller Healthcare India Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The mobile CT scanners are intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 30cm field of view, primarily the head and neck. The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast.