# K071542: Digital Stereoloc II

- Pathway: 510(k) (Special)
- Applicant: Lorad, A Hologic Co.
- Decided: Jul 5, 2007 after 30 days
- Product code: IZH (System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K941191 (1995). 5 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040884: Lorad Digital Spot Mammography System, Hologic, Inc. (2004) Summary page 1.
- K040125: Senographic Stereo, Ge Medical Systems, Inc. (2004) Summary page 1.

## Cited in the summary but kept off the family tree
- K950220: Hologic Lorad StereoLoc II. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Most influential descendants
- K103512: Affirm Breast Biopsy Guidance System (2011), 13 descendants of its own
- K122836: Affirm Breast Biopsy Guidance System (2013), 9 descendants of its own
- K173408: Mammomat Revelation (2018), 6 descendants of its own
- K193166: MAMMOMAT Revelation (2020), 4 descendants of its own
- K233539: MAMMOMAT B.brilliant (2024), 1 descendant of its own

## Indications for use
The Hologic Digital StereoLoc II is an optional accessory for the Selenia full field digital mammography system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from stereotactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).

Source page: https://510kreport.com/device/K071542
Methodology: https://510kreport.com/methodology