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_32f792cc96023af11154c12ec0608f97. 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.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Brand Name
3Dimensions System & Accessories
License Holder
Trivitron Healthcare Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
The Hologic Selenia Dimensions system generates digital mammographic images that can be used for screening and diagnosis of breast cancer. The Selenia Dimensions (3Dimensions System & Accessories) system is intended for use in the same clinical applications as a 2D mammography system for screening mammograms. Specifically, the Selenia Dimensions 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 Selenia Dimensions system may also be used for additional diagnostic workup of the breast
Computed Tomography System
Brand: TRIVITRON
Ultrasound Diagnostic Scanner
Brand: SonoRad
Automated Hematology Analyzer
Brand: Cellenium 21
Fully Automated Biochemistry Analyzer
Brand: Cellenium 21
Semi Automatic Biochemistry Analyzer
Brand: Cellenium 21
Semi Automatic Biochemistry Analyzer
Brand: Cellenium 21
5-Part-Diff Auto Hematology Analyzer
Brand: Cellenium 21
Covid Mutiplex RT-PCR kit with extraction free technology
Brand: COVIDsure DIRECT Mutiplex RT-PCR kit with extraction free technology
COVIDsure Multiplex Realtime RT-PCR Kit
Brand: RNAsure Pro
Auto-96 RNA EXTRACTION KIT
Brand: RNAsure Pro