Digital Mammography System
- UID
- IMP/MD/2021/000493_5f80e64366fc7f6e9be29834e4cf7336_c6edadd42ed9ed1f8326592765584662
- Device class
- Class C
- Brand name
- 3Dimensions System & Accessories
- License holder
- Trivitron Healthcare Pvt. Ltd.
- 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
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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