# K110025: Sectra Microdose Mammography

- Pathway: 510(k) (Traditional)
- Applicant: Sectra Imtec AB
- Decided: Apr 28, 2011 after 115 days
- Product code: MUE (Full Field Digital, System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1715
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P990066 (2000). 2 ancestors in all.
3 later devices descend from it; 2 cite 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)
- P050014: Fuji's Computed Radiography  Mammography Suite (Fcrms), Fujifilm Medical System U.S.A., Inc. (2006) Summary page 2.
- P990066: GE Healthcare Senographe Full Field Digital Mammography System, GE Healthcare (2000) Summary page 2.

## Most influential descendants
- K120255: Philips Microdose (2012), 2 descendants of its own
- K123995: Microdose SI (2013), 1 descendant of its own
- K130704: Microdose SI (2013), 0 descendants of its own

## Indications for use
The Sectra MicroDose Mammography L30 is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Sectra MicroDose Mammography L30 is intended to be used in the same clinical applications as traditional film/screen systems.

Source page: https://510kreport.com/device/K110025
Methodology: https://510kreport.com/methodology