# K163052: Brevera Biopsy System with Corlumina Imaging Technology

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Mar 29, 2017 after 148 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K021113 (2002). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042290: Vacuum Assisted Core Biopsy Device, Suros Surgical Systems, Inc. (2004) Summary page 4.
- K111508: Trident Specimen Radiography System, Model : RC Tri-00001, Hologic, Inc. (2011) Summary page 4.

## Most influential descendants
- K262792: Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) (2026), 0 descendants of its own

## Recalls of this device
- Dec 15, 2025 · Class II · Z-1314-2026: Presence of particulates in affected devices that can be deposited into breast tissue during use.

## Indications for use
The Hologic Brevera breast biopsy system with CorLumina imaging technology is intended to provide breast tissue samples for diagnostic sampling of breast abnormalities. The Brevera breast biopsy system excises targeted tissue and optionally delivers in-line radiographic images of the excised tissue. The Brevera breast biopsy system is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (for example, fibroadenoma, fibrocystic lesion), the Brevera breast biopsy system may also be used to partially remove such palpable lesions. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of histological abnormality, for example, malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedure.

Source page: https://510kreport.com/device/K163052
Methodology: https://510kreport.com/methodology