Hologic Selenia Dimensions Mammography System with Affirm Breast Biopsy Guidance System - HSA Registration DE0007867
Access comprehensive regulatory information for Hologic Selenia Dimensions Mammography System with Affirm Breast Biopsy Guidance System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0007867 and owned by Hologic Inc.. The device was registered on November 09, 2011.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The Selenia Dimensions System generates digital mammography images that can be used for screening and diagnosis of breast cancer. Specifically, the Selenia Dimensions system can be used to acquire 2D digital mammograms and 3D mammograms. The Selenia Dimensions system may also be used for additional diagnostic workup of the breast. Tomosynthesis is not approved for screening, and must be used in conjunction with conventional mammography (2D image set). The Hologic Affirm Breast Biopsy Guidance System is an optional accessory designed to allow the accurate location of lesions in the breast in three dimensions. It is intended to provide guidance for interventional purposes such as biopsy, pre-surgical localization or treatment devices. Affirm Contrast Biopsy is intended for patients recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities.