# P010025: Lorad Digital Breast Imager

- Pathway: PMA
- Applicant: Hologic, Inc.
- Decided: Mar 15, 2002 after 319 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K162670: RSM 1824C with RConsole1 (2017), 4 descendants of its own
- K202902: 2430MCA with Xmaru W (2021), 1 descendant of its own
- K170930: RSM 2430C (2017), 1 descendant of its own
- K243849: 2430TCA with Xmaru W (2025), 0 descendants of its own
- K241113: Vivix-M (2025), 0 descendants of its own

## Recalls of this device
- Apr 8, 2026 · Class II · Z-2167-2026: Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
- May 13, 2014 · Class II · Z-1700-2014: Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury
- Sep 6, 2013 · Class II · Z-2301-2013: Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images
- Feb 28, 2008 · Not classified · Z-1546-2008: Marker Misalignment: The new software version contained a magnification factor that shows CAD markers misaligned with the identified indications. The marked area is misaligned up to 2cm from the indic

Source page: https://510kreport.com/device/P010025
Methodology: https://510kreport.com/methodology