# K123995: Microdose SI

- Pathway: 510(k) (Special)
- Applicant: Philips Digital Mammography Sweden AB
- Decided: Feb 1, 2013 after 37 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: 3 generations back to P990066 (2000). 4 ancestors in all.
1 later device descends 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)
- K110025: Sectra Microdose Mammography, Sectra Imtec AB (2011) Summary page 2.
- K120255: Philips Microdose, Philips Digital Mammography Sweden AB (2012) Summary page 2.

## Most influential descendants
- K130704: Microdose SI (2013), 0 descendants of its own

## Indications for use
The MicroDose SI (model L50) is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MicroDose SI (model L50) is intended to be used in the same clinical applications as traditional film/screen systems.

Source page: https://510kreport.com/device/K123995
Methodology: https://510kreport.com/methodology