Biopsy needles
Brevera Breast Biopsy System
An assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. This GMDN code includes stand-alone units as well as units that mount onto an existing mammographic radiographic unit.
Brevera Breast Biopsy System models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| BREV09 | — | MR Unsafe | Available |
| BREV100 | — | Not stated | Available |
| BREV200 | — | MR Unsafe | Available |
| BREVADPTR | — | MR Unsafe | Available |
| BREVADPTRG | — | MR Unsafe | Available |
| BREVADPTRM | — | MR Unsafe | Available |
| BREVDISP09 | — | MR Unsafe | Available |
| BREVDRV | — | MR Unsafe | Available |
| BREVDRV-02 | — | Not stated | Available |
| BREVSTXKIT | — | MR Unsafe | Available |
| BREVSTXKITG | — | MR Unsafe | Available |
| BREVSTXKITM | — | MR Unsafe | Available |
| BREVSTYLBRKT | — | MR Unsafe | Available |
| BREVTF01 | — | Not stated | Available |
| BREVTF12 | — | Not stated | Available |
FDA clearances
- 510(k) K163052 March 2017
Procedures that use biopsy needles
Frequently asked questions
What is Brevera Breast Biopsy System used for?
An assembly of devices intended to be used in conjunction with mammography to insert biopsy devices, typically designated needles, into a breast in order to extract a biopsy of a suspect tumour for diagnostic purposes. It consists of a biopsy unit with needle guides, needles, an examination table, and an integral computer for communicating lesion coordinates. This GMDN code includes stand-alone units as well as units that mount onto an existing mammographic radiographic unit.
Who makes Brevera Breast Biopsy System?
Brevera Breast Biopsy System is made by Hologic, Inc.. It is listed under biopsy needles and systems in our device library.
What sizes does Brevera Breast Biopsy System come in?
The FDA device database does not list sizes for Brevera Breast Biopsy System. Check the instructions for use or ask a Hologic, Inc. representative.
Is Brevera Breast Biopsy System MRI safe?
The FDA device database lists Brevera Breast Biopsy System as MR Unsafe. Always follow the specific MRI conditions in the labeling.
Is Brevera Breast Biopsy System FDA cleared?
Brevera Breast Biopsy System is covered by FDA submission K163052.
How do I contact a Hologic, Inc. sales representative?
Hologic, Inc. has not listed representatives on LA Vascular yet. Visit the Hologic, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.