# K120255: Philips Microdose

- Pathway: 510(k) (Traditional)
- Applicant: Philips Digital Mammography Sweden AB
- Decided: Apr 19, 2012 after 83 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: 2 generations back to P990066 (2000). 3 ancestors in all.
2 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)
- K110025: Sectra Microdose Mammography, Sectra Imtec AB (2011) Summary page 2.

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

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

Source page: https://510kreport.com/device/K120255
Methodology: https://510kreport.com/methodology