Digital Mammography System - India CDSCO Medical Device Registration
Digital Mammography System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000493_5f80e64366fc7f6e9be29834e4cf7336_c6edadd42ed9ed1f8326592765584662. This device is marketed under the brand name 3Dimensions System & Accessories. The license holder is Trivitron Healthcare Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
3Dimensions System & Accessories
License Holder
Trivitron Healthcare Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
The Hologic 3Dimensions system generates digital mammographic images that can be used for screening and diagnosis of breast cancer. The 3Dimensions (3Dimensions System & Accessories) system is intended for use in the same clinical applications as a 2D mammography system for screening mammograms. Specifically, the 3Dimensions system can be used to generate 2D digital mammograms and 3D mammograms. Each screening examination may consist of: • A 2D FFDM image set, or • A 2D and 3D image set, where the 2D image can be either a FFDM or a 2D image generated from the 3D image set The 3Dimensions system may also be used for additional diagnostic workup of the breast
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